Apparatus for controlling flow in a bodily organ

ABSTRACT

An apparatus for controlling a flow of urine in a urethra of a patient is disclosed, comprising an implantable constriction device for constricting the urethra to influence the flow in the urinary tract. The constriction device comprises a plurality of constriction elements configured to be arranged at different locations along the flow direction of the urethra, wherein each constriction element is configured to at least partly encircle the urethra and to be operable so as to change a constriction of the urethra. The apparatus further comprises an operation device configured to operate the constriction elements.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Application No.60/960,716, filed Oct. 11, 2007,the entire contents of which are herebyincorporated by reference in this application.

FIELD OF THE INVENTION

The present invention relates generally to a method for malecontraception that operates to close a vas deferens during a controlledperiod.

BACKGROUND OF THE INVENTION

There are diseases that prevent a patient from maintaining normalcontrol of the flow of fluids and/or other bodily matter in a lumen of abodily organ. (The term “patient” generally includes human beings, butmay also include animals.)

One prior solution to the problem of malfunctioning sphincters has beento implant an artificial sphincter that replaces a malfunctioningsphincter. A variety of artificial sphincters have been used in thepast. These artificial sphincters have included cuffs, clamping elementsor inflatable bands that are applied externally around the bodily organthat is connected to the malfunctioning sphincter.

U.S. Pat. No. 6,074,341 discloses a mechanical device in the form of aloop member that is applied around a bodily organ to replace the organ'smissing or damaged sphincter. The loop member includes a wire, which isused to constrict the organ in question to close the lumen therein.

Another more serious disadvantage is that the element that constricts ,clamps or restricts a bodily organ may injure the tissue wall of theorgan. Thus, a consequence of the element's constricting action on theorgan is that the element might erode into the organ over time, and in aworst case, penetrate the constricted wall portion of the organ. Inaddition, blood circulation in the constricted tissue wall portion ofthe organ is eventually hampered by the pressure exerted by the element,so that poor blood circulation, or worse, no blood circulation resultsin deterioration of the constricted tissue.

A common route of male contraception is occlusion of vas deferens (thesperm transporting duct). Vasectomy is a surgical intervention to cutvas deferens and is most frequently a confinement to permanentsterility. More recently, other alternatives have become available bythe provision of devices to be inserted into vas deferens and obtain asealing effect. One such technique is described in U.S. Pat. No.6,513,528 that relates to a set of silicone plugs for insertion into vasdeferens. However, even if this technology represents a possibility toreverse the individual to fertility is also associated with sideeffects, such as sperm antibody formation. It is therefore a need for amore gentle technique to obtain controlled male contraception whichadmits reversibility with minimal affection of body functions. Theobject of the present invention as it is outlined below is providing amethodology that provides more safety and convenience with malecontraception based occlusion of vas deferens or preventing sperm tomove up along vas deferens.

BRIEF SUMMARY OF THE INVENTION

In general terms, the present invention relates to a method for malecontraception a time-limited obtaining sterility of a male mammalianindividual by affecting the flow of sperm in the vas deferens vasdeferens during a controlled period. In this context restriction of vasdeferens means that the lumen of vas deferens is occluded or movementsare created to prevent flow in the lumen in a manner to prevent spermsto reach the urethra by operating on vas deferens from the outside. Theterms “vas deferens” may include one vas deferens or both vasadeferentia. When explaining the inventive methods of restricting of vasdeferens according to the invention also other terms like “lumen” or“tissue portion” or “body vas deferens” are used, but such terms shallbe regarded as functional synonyms and interchangeable with “vasdeferens”.

The object of the present invention is to provide a method of malecontraception by restricting the flow in the vas deferens so as to atleast substantially or even completely eliminate the injured tissue wallproblems. In accordance with this object of the present invention, thereis provided a method for controlling the flow in the vas deferens thatis formed by the tissue wall of a bodily organ, the method comprising:

a) gently constricting at least one portion of the tissue wall of vasdeferens to influence the flow in the vas deferens, or

b) stimulating at least one portion of the tissue wall of vas deferensto cause contraction of the wall portion to further influence the flowin the vas deferens.

In accordance with a most beneficial embodiment of the invention, themethod comprises:

a) gently constricting the tissue wall portion to influence the flow inthe vas deferens, and

b) stimulating the constricted wall portion to cause contraction of thewall portion of vas deferens to further influence the flow in the vasdeferens.

The present invention provides an advantageous combination of the methodsteps (a) and (b), which results in a two-stage influence on the flow offluids and/or other bodily matter in the vas deferens. Thus, applying arelatively weak force against the wall portion gently constricts thetissue wall and the constricted wall portion is stimulated to achievethe desired final influence on the flow in the lumen. The phrase “gentlyconstricts a portion of the tissue wall” is to be understood asconstricting the wall portion without substantially hampering the bloodcirculation in the tissue wall.

Preferably, step (b) is performed by intermittently and individuallystimulating different areas of the wall portion. Such an intermittentand individual stimulation of different areas of the wall portion of vasdeferens allows tissue of the wall portion to maintain over timesubstantially normal blood circulation.

The method of the present invention can be practiced on any place on anykind of bodily organs, in particular, but not limited to, tubular bodilyorgans, which is a significant advance in the art, as compared withprior stimulation devices that are confined to electric stimulation ofmalfunctioning sphincters. Preferably, the constriction step (a) andstimulation step (b) are performed independently of each other. Steps(a) and (b) may be performed simultaneously. Optionally, step (b) may ormay not be performed while step (a) is performed.

Initially, the constriction of the wall portion can be calibrated bystimulating the wall portion while adjusting the constriction of thewall portion until the desired restriction of the flow in the lumen isobtained.

Flow Restriction

It should be understood that any embodiment or part of embodimentdisclosed below in connection with flow restriction for the constrictionand stimulation devices combined in the constriction/stimulation unitcould be used for the separate constriction device and separatestimulation device, where applicable. The method of the presentinvention is well suited for restricting the flow of fluids and/or otherbodily matter in the lumen of a bodily organ. Thus, in a principalembodiment of the invention, the wall portion is constricted, so thatthe flow in the lumen at least is restricted and the constricted wallportion is stimulated to at least further restrict the flow in thelumen. Specifically, the wall portion is constricted to a constrictedstate, in which the blood circulation in the constricted wall portion issubstantially unrestricted and the flow in the lumen is at leastrestricted, and the constricted wall portion is stimulated when it is inthe constricted state to at least further restrict the flow in thelumen.

The constriction step (a) and stimulation step (b) are suitablyperformed to constrict and stimulate the wall portion to an extent thatdepends on the flow restriction that is desired to be achieved in aspecific application of the method of the invention. Thus, in accordancewith a first flow restriction option, step (a) is performed byconstricting the wall portion, so that the flow in the lumen isrestricted but not stopped, and step (b) is performed by stimulating theconstricted wall portion to cause contraction thereof, so that the flowin the lumen is further restricted but not stopped. The method mayfurther comprise sensing a physical parameter of the patient andadjusting the intensity of the stimulation of the wall portion inresponse to the sensed parameter.

In accordance with a second flow restriction option, step (a) isperformed by constricting the wall portion, so that the flow in thelumen is restricted but not stopped, and step (b) is performed bystimulating the constricted wall portion to cause contraction thereof,so that the flow in the lumen is stopped.

When using the method of the invention in accordance with the first orsecond options, the method may further comprise (c) ceasing stimulatingthe wall portion to increase or allow the flow in the lumen and (d)releasing the wall portion to restore the flow in the lumen.

In accordance with a third flow restriction option, step (a) isperformed by constricting the wall portion, so that the flow in thelumen is substantially stopped, and step (b) is performed by stimulatingthe constricted wall portion to cause contraction thereof, so that theflow in the lumen is completely stopped. The method may further comprise(c) ceasing stimulating the wall portion to allow the flow in the lumenand (d) releasing the wall portion to restore the flow in the lumen.

Where the constricted wall portion is stimulated to contract, so thatthe flow in the lumen is stopped, a first length of the constricted wallportion and a second length of the constricted wall portion, which islocated downstream of the first length, are suitably simultaneously andcyclically stimulated, wherein the first length is progressivelystimulated in the upstream direction of the lumen and the second lengthis progressively stimulated in the downstream direction of the lumen.

Furthermore, when using the method of the invention in accordance withthe second and third options, the method may further comprise sensing aphysical parameter of the patient or functional parameter of implantedcomponents and adjusting the stimulation of the wall portion in responseto the sensed parameter. For example, the intensity of the stimulationof the wall portion may be increased in response to a sensed pressureincrease in the lumen, so that the flow in the lumen remains stoppedwhen a pressure increase occurs in the lumen. In particular, the methodmay comprise sensing a physical parameter of the patient's that relatesto the pressure in the lumen, and controlling the stimulation of thewall portion in response to the sensed parameter. Any sensor for sensinga physical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure in the lumen may be provided, whereinthe stimulation is controlled in response to signals from the sensor.Such a sensor may for example sense the pressure in the patient'sabdomen, the pressure against the implanted constriction device or thepressure on the tissue wall of the bodily organ.

In accordance with a fourth restriction option, step (a) is performed byconstricting the wall portion, so that the flow in the lumen is stopped.When needed, the wall portion is released to restore the flow in thelumen. Step (b) is only performed by stimulating the constricted wallportion to cause contraction thereof, so that the flow in the lumenremains stopped when a pressure increase occurs in the lumen. The methodmay further comprise sensing a physical parameter of the patient's body,such as a pressure in the patient's body that relates to the pressure inthe lumen, and controlling the stimulation of the wall portion inresponse to the sensed parameter. Such a physical parameter may be apressure in the patient's abdomen and the sensor may be a pressuresensor.

In some applications of the method of the invention, continuousstimulation may over time change the physical properties of the tissueso that the tissue might be injured. Also, the effect of a continuousstimulation of the tissue wall may decrease over time. Therefore, step(b) is preferably performed by intermittently and individuallystimulating different areas of the wall portion so that the flow in thelumen continues to be restricted as desired and each area of the wallportion essentially maintains its natural physical properties over timeto prevent the area from being injured. Advantageously, each area of thewall portion is stimulated during successive time periods, each timeperiod being short enough to maintain over time satisfactory bloodcirculation in the area. Thus, the areas are stimulated so that an areathat currently is not stimulated will have time to restore substantiallynormal blood circulation before it is stimulated again.

To maintain satisfactory blood circulation in the tissue wall of thepatient's organ stimulation step (b) is suitably performed bystimulating one or more of different areas of the wall portion at atime, preferably by sequentially stimulating the different areas of thewall portion or by shifting the stimulation from one area to anotherover time. Preferably, stimulation step (b) is performed by cyclicallypropagating the stimulation of the areas along the wall portion, forexample in accordance with a determined stimulation pattern.

The method of the invention may further comprise controlling, preferablyby the patient, the constriction and/or stimulation of the wall portionfrom outside the patient's body.

Generally, the method of the invention comprises sensing a physicalparameter of the patient and controlling, preferably automatically, theconstriction and/or stimulation of the wall portion in response to thesensed parameter.

The constriction step (a) may be performed by constricting any wallportions of a series of wall portions of the organ's tissue wall,respectively, either in random or in accordance with a predeterminedsequence. The stimulation step (b) may be performed by stimulating anyof the constricted wall portions of the series of wall portions.Specifically, step (a) may be performed by constricting all of the wallportions of the series of wall portions, and step (b) may be performedby stimulating any constricted wall portions in random or in accordancewith a predetermined sequence to close the organ's lumen.

Moving Sperms in the Lumen or Preventing the Movement of Sperms in theLumen in a Similar Way.

It should be understood that any embodiment or part of embodimentdisclosed below in connection with moving sperms in the lumen, orpreventing the move of sperms in the lumen, for the constriction andstimulation devices combined in the constriction/stimulation unit couldbe used for the separate constriction device and separate stimulationdevice, where applicable. The method of the present invention can bepractised for actively moving the fluid and/or other bodily matter inlumen of a patient's organ. Thus, in the embodiments of the inventionlisted below, steps (a) and (b) are co-operated to move the fluid and/orother bodily matter in the lumen.

1) Step (a) is performed by constricting the wall portion to restrictthe flow in the lumen, and step (b) is performed by stimulating theconstricted wall portion to close the lumen either at an upstream end ora downstream end of the constricted wall portion. The method furthercomprises (c) increasing the constriction of the wall portion to movethe fluid and/or other bodily matter in the lumen.

2) Step (a) is performed by constricting the wall portion to restrictthe flow in the lumen, and step (b) is performed by progressivelystimulating the constricted wall portion to cause progressivecontraction of the wall portion to move the fluid and/or other bodilymatter in the lumen. The constricted wall portion is progressivelystimulated in the downstream or upstream direction of the lumen.

3) Step (a) is performed by varyingly constricting the wall portion tovary the flow in the lumen, and step (b) is performed by progressivelystimulating the constricted wall portion to cause progressivecontraction of the wall portion to move the fluid and/or other bodilymatter in the lumen. The constricted wall portion is progressivelystimulated in the downstream or upstream direction of the lumen.

4) Step (a) is performed by varyingly constricting different areas ofthe wall portion to cause progressive constriction of the wall portionin the downstream or upstream direction of the lumen, and theconstricted wall portion is progressively stimulated to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion. The method may further compriseproviding at least one elongated constriction element extending alongthe wall portion, and controlling the elongated constriction element toprogressively constrict the wall portion in the downstream or upstreamdirection of the lumen. The elongated constriction element suitablycomprises contact surfaces dimensioned to contact a length of wallportion, and the method may further comprise providing a plurality ofstimulation elements distributed along the contact surfaces, andcontrolling the stimulation elements to stimulate the different areas ofthe wall portion along the length of the wall portion.

5) Step (a) is performed by constricting any one of a series of wallportions of the tissue wall to at least restrict the flow in the lumen,and step (b) is performed by stimulating the constricted wall portion toclose the lumen. The method further comprises successively constrictingthe wall portions of the series of wall portions to move the fluidand/or other bodily matter in the lumen in a peristaltic manner.

5a) In accordance with an alternative, the method further comprisesproviding at least one constriction element and at least one stimulationelement positioned on the constriction element, moving the constrictionelement along the organ in the flow direction in the lumen tosuccessively constrict the wall portions of the series of wall portions,and using the stimulation element to stimulate the wall portionconstricted by the constriction element to close the lumen. Suitably,the method further comprises cyclically moving the constriction elementalong the wall portions of the series of wall portions.

5b) In accordance with another alternative, the method further comprisesproviding a plurality of constriction elements and stimulation elementspositioned on the constriction elements, moving each constrictionelement along the organ to successively constrict the wall portions ofthe series of wall portions, and using the stimulation elements tostimulate the wall portion constricted by any one of the constrictionelements to close the lumen. Suitably, the method further comprisescyclically moving the constriction elements one after the other alongthe wall portions of the series of wall portions. Specifically, themethod further comprises providing a rotor carrying the constrictionelements, and rotating the rotor so that each constriction elementcyclically constricts the wall portions of the series of wall portions.Each constriction element suitably comprises a roller that rolls on theorgan to constrict the latter.

6) Step (a) is performed by constricting any wall portions of a seriesof wall portions of the organ's tissue wall, respectively, wherein thewall portions of the series of wall portions are successivelyconstricted along the organ to move the fluid and/or other bodily matterin the lumen of the patient's organ. The stimulation step (b) isperformed by stimulating any constricted wall portions of the series ofwall portions.

7) Step (a) is performed by constricting wall portions of a series ofwall portions without completely closing the organ's lumen, and step (b)is performed by stimulating the constricted wall portions one after theother, so that the wall portions of the series of wall portions aresuccessively contracted along the organ to move the fluid and/or otherbodily matter in the lumen of the patient's organ.

8) Step (a) is performed by constricting the wall portion at an upstreamor downstream end thereof to close the lumen. The method furthercomprises (c) constricting the wall portion between the upstream anddownstream ends thereof, to move the fluid or other bodily mattercontained in the wall portion between the upstream and downstream endsthereof downstream or upstream in the lumen. Optionally, the methodfurther comprises stimulating the wall portion between the upstream anddownstream ends thereof, as (c) is performed.

8a) In accordance with an alternative, step (a) is performed byconstricting the wall portion at the upstream end thereof to restrictthe flow in the lumen, and step (b) is performed by stimulating theconstricted wall portion at the upstream end to close the lumen, wherebythe fluid and/or other bodily matter contained in the wall portionbetween the upstream and downstream ends thereof is moved downstream inthe lumen, as step (c) is performed.

8b) In accordance with another alternative, step (a) is performed byconstricting the wall portion at the downstream end thereof to restrictthe flow in the lumen, and step (b) is performed by stimulating theconstricted wall portion at the downstream end to close the lumen,whereby the fluid and/or other bodily matter contained in the wallportion between the upstream and downstream ends thereof is movedupstream in the lumen, as step (c) is performed.

Where the organ is tubular in shape, such as the small intestines, aparticularly long wall portion of the tubular organ may be surgicallyprepared to extend in zigzag with adjacent walls stitched together bytwo parallel rows of stitches and with the adjacent walls cut throughbetween the two rows of stitches. As a result, the lumen of this longwall portion of the organ can be significantly expanded. In this case, aconsiderably larger volume of fluid is moved in the organ each time step(a) and/or step (b) is performed.

To summerize a few prefered embodiments see below:

In accordance with an alternative, step (a) is performed by constrictingany wall portions of a series of wall portions of the organ's tissuewall, respectively. In accordance with an alternative, the wall portionsof the series of wall portions are constricted in random or inaccordance with a predetermined sequence. In accordance with analternative, the wall portions of the series of wall portions aresuccessively constricted along the organ to move the fluid and/or otherbodily matter in the lumen of the patient's organ or to prevent thefluid and/or other bodily matter to move in the lumen of the patient'sorgan.

In accordance with an alternative, step (b) is performed by stimulatingany constricted wall portions of the series of wall portions. Inaccordance with an alternative, the wall portions of the series of wallportions are constricted in random or in accordance with a predeterminedsequence. In accordance with an alternative, wherein the wall portionsof the series of wall portions are successively constricted along theorgan to move the fluid and/or other bodily matter in the lumen of thepatient's organ or to prevent the fluid and/or other bodily matter tomove in the lumen of the patient's organ.

In accordance with an alternative, step (a) is performed by constrictingany wall portions of a series of wall portions of the organ's tissuewall, respectively, wherein the wall portions of the series of wallportions are successively constricted without completely closing theorgan's lumen, and step (b) is performed by stimulating the constrictedwall portions, so that the wall portions of the series of wall portionsare further constricted. In accordance with an alternative, the wallportions of the series of wall portions are constricted in random or inaccordance with a predetermined sequence.

In accordance with an alternative, wherein the wall portions of theseries of wall portions are successively constricted along the organ tomove the fluid and/or other bodily matter in the lumen of the patient'sorgan or to prevent the fluid and/or other bodily matter to move in thelumen of the patient's organ.

In accordance with an alternative, step (a) is performed by constrictingall of the wall portions of the series of wall portions, and step (b) isperformed by stimulating any constricted wall portions so that the wallportions of the series of wall portions are further constricted.

In accordance with an alternative, the wall portions of the series ofwall portions are further constricted by the stimulation device inrandom or in accordance with a predetermined sequence.

In accordance with an alternative, the wall portions of the series ofwall portions are successively further constricted by the stimulationdevice along the organ to move the fluid and/or other bodily matter inthe lumen of the patient's organ or to prevent the fluid and/or otherbodily matter to move in the lumen of the patient's organ.

A method for controlling a flow of sperms in an vas deferens of a femalepatient, the method comprising:

-   -   applying influence on at least one portion of the vas deferens        wall of a vas deferens portion, and    -   controlling the influence to influence the flow of sperms in the        vas deferens portion.

A method, wherein the step of influencing comprises stimulating the vasdeferens wall portion to cause contraction of the vas deferens wallportion to influence the flow of sperms in the vas deferens.

A method, wherein the step of influencing comprises constricting thewall portion of the vas deferens wall to constrict the vas deferens wallportion, to cause contraction of the vas deferens wall portion toinfluence the flow of sperms in the vas deferens.

A method, wherein the step of contracting the vas deferens wall portioncomprising contracting any wall portions of a series of wall portions ofthe vas deferens's wall, respectively, wherein the vas deferens wallportions of the series of wall portions are contracted in random or inaccordance with a predetermined sequence.

The method further comprising, the vas deferens wall portions of theseries of wall portions are successively contacted along the vasdeferens to move the sperms in the vas deferens or to prevent the spermsto move in the vas deferens.

The method, further comprising contracting the vas deferens wallportions of the series of wall portions at least two at a time atpositions spaced apart on the vas deferens, thus creating a closed spacein the lumen of the vas deferens, wherein one contracted wall portion isplaced proximal and one wall portion is placed distal on the vasdeferens, the further method comprising the steps of;

opening and closing said closed space or

varying the position of said closed space.

The method, further comprising two or more closed spaces, the furthermethod comprising the steps of;

opening and closing said closed spaces according, to a predeterminedsequence, or

varying the position of said closed spaces along the vas deferens,according to a predetermined sequence, to prevent any sperm to pass allthe contracted wall portions for a period exceeding 3-5 days.

In accordance with an alternative for all applicable alternatives, step(a) and step (b) are performed independently of each other or inaccordance with an alternative, step (a) and step (b) are performedsimultaneously.

In any of the above noted embodiments (1) to (8b), step (b) may beperformed by stimulating the wall portion with electric pulses.

Stimulation Modes

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time if the stimulation is not properlyperformed. The method of the present invention is performed to reduce oreven eliminate that risk. Thus, step (b) is performed by intermittentlystimulating different areas of the wall portion so that at least two ofthe areas are stimulated at different points of time. I.e., thestimulation is shifted from one area to another area over time. Inaddition, step (b) is performed by intermittently stimulating the areasof the wall portion so that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before it is stimulated again. Furthermore, step (b)is performed by intermittently stimulating the areas during successivetime periods, wherein each time period is short enough to maintainsatisfactory blood circulation in the area until the laps of the timeperiod. This gives the advantage that the method of the presentinvention provides continuous stimulation of the wall portion of theorgan to achieve the desired flow control while essentially maintainingover time the natural physical properties of the organ without risk ofinjuring the organ.

Also, by physically changing the places of stimulation on the organ overtime as described above it is possible to create an advantageouschanging stimulation pattern on the organ, in order to achieve a desiredflow control.

To achieve the desired reaction of the tissue wall during thestimulation thereof, step (b) may be performed by stimulating the wallportion with, preferably cyclically, varying stimulation intensity.

In a main embodiment of the invention, step (b) is performed byintermittently stimulating the wall portion with pulses, preferably inthe form of pulse trains. The pulse trains can be configured in manydifferent ways by varying pulse parameters. Thus, the pulse amplitudesof the pulses of the pulse trains, the off time periods between theindividual pulses of each pulse train and the width and repetitionfrequency of each pulse may be varied. Also the off time periods betweenthe pulse trains may be varied, wherein each off time period between thepulse trains is kept long enough to restore substantially normal bloodcirculation in each area of the wall portion, when the area is notstimulated during the off time periods. Furthermore, the repetitionfrequency of the pulses of the pulse trains and the length and number ofpulses of each pulse train may be varied.

As mentioned above, for reasons of maintaining over time the effect ofstimulation, it is preferable that different areas of the wall portionare intermittently and individually stimulated. In consequence, step (b)may be performed by stimulating one or more of the areas at a time withpulses, by cyclically propagating the stimulation of the areas withpulses along the wall portion, and/or by propagating the stimulation ofthe areas with pulses in accordance with a determined stimulationpattern. In case the off time periods between pulse trains thatstimulate the respective area of the wall portion are varied, it ispreferable that each off time period between the pulse trains iscontrolled to last long enough to restore substantially normal bloodcirculation in the area when the latter is not stimulated during the offtime periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, step (b) isperformed by electrically stimulating the wall portion, preferably withelectric pulses to cause contraction of the wall portion. Thisembodiment is particularly suited for applications in which thepatient's wall portion includes muscle fibers that react to electricalstimula. Thus, the wall portion that includes the muscle fibers isstimulated with such electric pulses, preferably in the form of electricpulse trains, when the wall portion is in the constricted state, tocause contraction of the wall portion. Of course, the configuration ofthe electric pulse trains may be similar to the above described pulsetrains and different areas of the wall portion may be electricallystimulated in the same manner as described above.

In accordance with the preferred embodiment, the method of the inventioncomprises providing at least one, preferably a plurality of electricalelements, such as electrodes, engaging and stimulating the wall portionwith electric pulses. Optionally, the electrical elements may be placedin a fixed orientation relative to one another. The method compriseselectrically energizing the electrical elements, preferably bycyclically energizing each element with electric pulses. The electricalelements may be energized so that the electrical elements are energizedone at a time in sequence, or so that a number or groups of theelectrical elements are energized at a time. Also, groups of electricalelements may be sequentially energized, either randomly or in accordancewith a predetermined pattern.

The method may further comprise applying the electrical elements on thepatient's wall portion so that the electrical elements form any patternof electrical elements, preferably an elongate pattern of electricalelements extending lengthwise along the wall portion and the elementsabut the respective areas of the wall portion. The electrical elementsmay be successively energized along the elongate pattern of electricalelements in a direction opposite to or in the same direction as that ofthe flow in the patient's lumen. Optionally, the electrical elements maybe successively energized along the elongate pattern of electricalelements from a position substantially at the center of the constrictedwall portion towards both ends of the elongate pattern of electricalelements. Where the lumen of the organ is to be kept closed for arelatively long time, the electrical elements may be energized so thatenergized electrical elements form two waves of energized electricalelements that simultaneously advance from the center of the constrictedwall portion in two opposite directions towards both ends of theelongate pattern of electrical elements. Such waves of energizedelectrical elements can be repeated over and over again without harmingthe organ and without moving fluid or gas in any direction in the lumenof the organ.

The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the organ. Each row ofelectrical elements may form a straight, helical or zig-zag path ofelectrical elements, or any form of path. The electrical elements may beenergized so that the electrical elements currently energized form atleast one group of adjacent energized electrical elements, wherein theelements in the group of energized electrical elements form a path ofenergized electrical elements extending at least in part around thepatient's organ, preferably completely around the patient's organ.Alternatively, the elements in the group of energized electricalelements form two paths of energized electrical elements extending onmutual sides of the patient's organ or more than two paths of energizedelectrical elements extending on different sides of the patient's organ,preferably at least substantially transverse to the flow direction inthe lumen of the organ.

In an embodiment of the invention, the electrical elements form aplurality of groups of elements, wherein the groups form a series ofgroups extending along the patient's organ in the flow direction in thepatient's lumen. The electrical elements of each group of electricalelements may form a path of elements extending at least in part aroundthe patient's organ. In a first alternative, the electrical elements ofeach group of electrical elements may form more than two paths ofelements extending on different sides of the patient's organ, preferablysubstantially transverse to the flow direction in the patient's lumen.The groups of electrical elements in the series of groups may beenergized in random or in accordance with a predetermined pattern.Alternatively, the groups of electrical elements in the series of groupsmay be successively energized in a direction opposite to or in the samedirection as that of the flow in the patient's lumen, or in both saiddirections starting from a position substantially at the center of theconstricted wall portion. For example, groups of energized electricalelements may form advancing waves of energized electrical elements, asdescribed above. I.e., the groups of electrical elements may beenergized so that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

Thermal Stimulation

In accordance with an embodiment of the invention, stimulation step (b)is performed by thermally stimulating the wall portion. Thus, the wallportion may be cooled, when the wall portion is constricted, to causecontraction of the wall portion. For example, the wall portion may beconstricted to at least restrict the flow in the lumen, and theconstricted wall portion may be cooled to cause contraction thereof, sothat the flow in the lumen is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the wall portionmay be heated, when the wall portion is constricted and contracted, tocause expansion of the wall portion. Where the wall portion includes ablood vessel, the blood vessel may be cooled to cause contractionthereof, or heated to cause expansion thereof. Where applicable, thermalstimulation may be practised in any of the embodiments of the presentinvention. Where applicable, thermal stimulation may be practised in anyof the embodiments of the present invention, and the thermal stimulationmay be controlled in response to various sensors, for example strain,motion or pressure sensors.

Constriction and Stimulation Devices

It should be understood that any embodiment or part of embodiment forthe combined stimulation device and constriction device, could be used,if applicable, for any one of the devices as a stand alone device.Generally, the method of the invention comprises providing aconstriction device that constricts the wall portion, a stimulationdevice that stimulates the constricted wall portion and a control devicethat controls the constriction device and/or the stimulation device. Themethod comprises operating the control device from outside the patient'sbody, preferably by using the control device to wirelessly control theconstriction device and/or stimulation device. The wireless control ispreferably performed in a non-magnetic manner, whereby implantedmagnetic devices can be avoided. Suitably, the control device comprisesa hand-held wireless remote control operated by the patient.

Alternatively, the control device comprises a manually operable switchfor switching on and off the constriction device and/or stimulationdevice. In this case, the method comprises subcutaneously implanting theswitch in the patient and manually operating the the implanted switchfrom outside the patient's body.

In an embodiment of the invention, the control device comprises aprogrammable internal control unit, such as a microprocessor, and themethod comprises implanting in the patient the internal control unit andcontrolling by the internal control unit the constriction device and/orstimulation device. The control device may also comprise an externalcontrol unit outside the patient's body. In this case, the methodcomprises controlling by the external control unit the constrictiondevice and/or stimulation device and, optionally, using the externalcontrol unit to program the implanted internal control unit. Theinternal control unit may be programmable for controlling theconstriction device and/or stimulation device over time, for example inaccordance with an activity schedule program.

The constriction of the wall portion can be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the lumen is obtained.

Sensor Controlled Constriction and/or Stimulation

It should be understood that any embodiment or part of embodimentdisclosed below in connection with sensor control of the constrictionand stimulation devices combined in the constriction/stimulation unitcould be used for the separate constriction device and separatestimulation device, where applicable. In an embodiment of the invention,the method comprises implanting at least one sensor and controlling bythe control device the constriction device and/or the stimulation devicein response to signals from the sensor. Generally, the sensor directlyor indirectly senses at least one physical parameter of the patient,functional parameter of the apparatus, or functional parameter of amedical implant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing organ motion, i.e. naturalcontractions, such as stomach or intestinal contractions, pressuresensors for sensing pressure in the organ, strain sensors for sensingstrain of the organ, flow sensors for sensing fluid flow in the lumen ofthe organ, spectro-photometrical sensors, Ph-sensors for acidity oralkalinity of the fluid in the lumen of the organ, oxygen-sensorssensors for sensing the oxygen content of the fluid in the lumen of theorgan, or sensors for sensing the distribution of the stimulation on thestimulated organ. Any conceivable sensors for sensing any other kind ofuseful physical parameter may be used.

Many different kinds of sensors that sense functional parameters ofimplanted components may also be used for the control of theconstriction device and/or the stimulation device. For example sensorsfor sensing electric parameters of implanted electric components, orsensors for sensing the performance of implanted motors or the like.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the lumen of the patient's bodily organ. In this case, the methodsuitably comprises operating the control device to control theconstriction device to change the constriction of the patient's wallportion in response to the pressure sensor sensing a predetermined valueof measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the lumen during different time periods of the day. In case a sensorof any of the above-described types for sensing a physical or functionalparameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism. Alternatively, the controldevice may comprise an external control unit outside the patient's bodyfor controlling the constriction device and/or stimulation device inresponse to signals from the sensor.

Constriction of Patient's Organ

It should be understood that any embodiment or part of embodimentdisclosed below in connection with constricting the patient's organcould be used for the separate constriction device and separatestimulation device, where applicable. Method step (a) may be performedin many different ways. Thus, step (a) may be performed by:

(1)—constricting the wall portion so that the through-flow area of thelumen assumes a size in the constricted state small enough to cause theconstricted wall portion to contract to stop the flow in the lumen whenstep (b) is performed;

(2)—bending the wall portion;

(3)—clamping the wall portion between at least two elements positionedon different sides of the organ;

(4)—clamping the organ between an element and the bone or tissue of thepatient;

(5)—rotating at least two elements positioned on different sides of theorgan;

or

(6)—clamping the organ between at least two articulated clampingelements positioned on different sides of the organ.

In the above noted alternatives (1) to (6) of method step (a), theconstriction of the wall portion of the organ may be changed eithermechanically or hydraulically. For many applications of the presentinvention, step (a) is suitably performed so that the through-flow areaof the lumen assumes a size in the constricted state that is smallenough to enable the stimulation during step (b) to contract the wallportion of the organ to stop the flow in the lumen.

Where the constriction of the wall portion is hydraulically changed, themethod of the invention may further comprise implanting in the patient areservoir containing a predetermined amount of hydraulic fluid, and aconstriction device engaging the wall portion and having anexpandable/contractible cavity, wherein step (a) is performed bydistributing hydraulic fluid from the reservoir to increase the volumeof the cavity to constrict the wall portion, and by distributinghydraulic fluid from the cavity to the reservoir to decrease the volumeof the cavity to release the wall portion. The cavity may be defined bya balloon of the constriction device that abuts the tissue wall portionof the patient's organ, so that the patient's wall portion isconstricted upon expansion of the cavity and released upon contractionof the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the following embodiments of the invention are conceivable.

1) The reservoir comprises first and second wall portions, and step (a)is performed by displacing the first and second wall portions relativeto each other to change the volume of the reservoir, so that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) At least one of a magnetic device, a hydraulic device or an electriccontrol device displaces the first and second wall portions of thereservoir.

2) A pump is provided for pumping fluid between the reservoir and thecavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

2a1) The first and second activation members are operable by manualmanipulation thereof.

2a2) At least one of the activation members operates when subjected toan external predetermined pressure.

2a3) At least one of the first and second activating members is operableby magnetic means, hydraulic means, or electric control means.

2b) A fluid conduit between the pump and the cavity is provided, whereinthe reservoir forms part of the conduit. The conduit and pump are devoidof any non-return valve. The reservoir forms a fluid chamber with avariable volume, and the pump distributes fluid from the chamber to thecavity by a reduction in the volume of the chamber and withdraws fluidfrom the cavity by an expansion of the volume of the chamber. A motor isprovided for driving the pump, wherein the pump comprises a movable wallof the reservoir for changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, hydraulic fluid is distributedbetween the reservoir and the cylinder/piston mechanism to adjust theconstriction device.

3) The method further comprises implanting a reverse servo operativelyconnected to the hydraulic means. The term “reverse servo” is to beunderstood as a mechanism that transfers a strong force acting on amoving element having a short stroke into a weak force acting on anothermoving element having a long stroke; i.e., the reverse function of anormal servo mechanism. Thus, minor changes in the amount of fluid in asmaller reservoir could be transferred by the reverse servo into majorchanges in the amount of fluid in a larger reservoir.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operated to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir, sothat the volume of the main reservoir is changed when the volume of theexpandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the method comprises dimensioning the servo and mainreservoirs, so that when the volume of the servo reservoir is changed bya relatively small amount of servo fluid, the volume of the mainreservoir is changed by a relatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaced relative to each other by manualmanipulation, a magnetic device, a hydraulic device, or an electriccontrol device to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means includes a hydraulically operablemechanical construction, the reverse servo described above may be used.In a further embodiment of the invention, the hydraulic means includefirst and second hydraulically interconnected expandable/contractiblereservoirs. The first reservoir is operatively connected to theconstriction device, so that the constriction device changes theconstriction of the patient's wall portion upon expansion or contractionof the first reservoir. By changing the volume of the second reservoirhydraulic fluid is distributed between the two reservoirs, so that thefirst reservoir is either expanded or contracted. This embodimentrequires no non-return valve in the fluid communication conduits betweenthe two reservoirs, which is beneficial to long-term operation of thehydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, so thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements extending along the wall portionon different sides of the organ. The hydraulic means, which may includethe reverse servo described above, hydraulically moves the elongatedclamping elements towards the organ to constrict the wall portion of theorgan. For example, the constriction device may have hydraulic chambersin which the clamping elements slide back and forth, and the hydraulicmeans may also include a pump and an implantable reservoir containinghydraulic fluid. The pump distributes hydraulic fluid from the reservoirto the chambers to move the clamping elements against the wall portion,and distributes hydraulic fluid from the chambers to the reservoir tomove the clamping elements away from the wall portion.

Energy Supply

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the power of the constriction andstimulation devices combined in the constriction/stimulation unit couldbe used for the separate constriction device and separate stimulationdevice, where applicable. Generally, method step (a) is performed byusing the constriction device and step (b) is performed by using thestimulation device, wherein the method further comprises forming theconstriction and stimulation devices in an operableconstriction/stimulation unit.

In a simple form of the invention, the method comprises implanting asource of energy, such as a battery, rechargeable battery oraccumulator, releasing energy from the source of energy and using thereleased energy in connection with the operation of theconstriction/stimulation unit.

In a more sophisticated form of the invention, which is preferable, themethod comprises transmitting wireless energy from outside the patient'sbody to inside the patient's body and using the transmitted wirelessenergy in connection with the operation of the constriction/stimulationunit.

Transmission of Wireless Energy

It should be understood that any embodiment or part of embodimentdisclosed below in connection with wireless control or power of theconstriction and stimulation devices combined in theconstriction/stimulation unit could be used for the separateconstriction device and separate stimulation device, where applicable.The wireless energy may be directly used in connection with theoperation of the constriction/stimulation unit, as the wireless energyis being transmitted. For example, the wireless energy may betransmitted in the form of an electric, an electromagnetic or a magneticfield, or a combination thereof, or electromagnetic waves for directpower of the constriction/stimulation unit. For example, where anelectric motor or pump operates the constriction device of theconstriction/stimulation unit, wireless energy in the form of a magneticor an electromagnetic field may be used for direct power of the motor orpump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy. Such components may include coilsintegrated in the motor or pump.

The wireless energy is suitably transmitted in pulses or digital pulses,or a combination of pulses and digital pulses.

Preferably, the wireless energy is transmitted in at least one wirelesssignal, suitably a wave signal. The wave signal may comprise anelectromagnetic wave signal including one of an infrared light signal, avisible light signal, an ultra violet light signal, a laser signal, amicrowave signal, a radio wave signal, an x-ray radiation signal, and agamma radiation signal. Alternatively, the wave signal may comprise asound or an ultrasound wave signal. The wireless signal may be a digitalor analogue signal, or a combination of a digital and analogue signal.

In accordance with a particular embodiment of the invention, thewireless energy is not for direct use in connection with the operationof the constriction/stimulation unit. In this embodiment the wirelessenergy comprises energy of a first form, which is transmitted intoenergy of a second form suited to operate the constriction/stimulationunit. Typically, the energy of the second form is different from theenergy of the first form. For example, the wireless energy of the firstform may comprise sound waves, whereas the energy of the second form maycomprise electric energy. Optionally, one of the energy of the firstform and the energy of the second form may comprise magnetic energy,kinetic energy, sound energy, chemical energy, radiant energy,electromagnetic energy, photo energy, nuclear energy or thermal energy.Preferably, one of the energy of the first form and the energy of thesecond form is non-magnetic, non-kinetic, non-chemical, non-sonic,non-nuclear or non-thermal.

Transforming Wireless Energy

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the control or energizing of theconstriction and stimulation devices combined in theconstriction/stimulation unit could be used for the separateconstriction device and separate stimulation device, where applicable.In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. Optionally, oneof the energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function different from or similar tothe energy-transmission device. Advantageously, the energy-transformingdevice comprises at least one element, such as at least onesemiconductor, having a positive region and a negative region, whenexposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy of the first form may directly or indirectly be transformedinto the energy of the second form. The method of the invention maycomprise providing a motor for operating the constriction device andpowering the motor with the energy of the second form. The constrictiondevice may be operable to perform at least one reversible function andthe method may comprise reversing the function by using the motor. Forexample, the method may comprise shifting the polarity of the energy ofthe second form to reverse the motor.

The motor may be directly powered with the transformed energy, as theenergy of the second form is being transformed from the energy of thefirst form. Preferably, the constriction/stimulation unit is directlyoperated with the energy of the second form in a non-magnetic,non-thermal or non-mechanical manner.

Normally, the implanted constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Therefore, theenergy of the first form may be transformed into a direct current orpulsating direct current, or a combination of a direct current andpulsating direct current. Alternatively, the energy of the first formmay be transformed into an alternating current or a combination of adirect and alternating current.

The method of the invention may comprise implanting in the patient aninternal source of energy, and supplying energy from the internal sourceof energy for the operation of the constriction/stimulation unit. Themethod may further comprise implanting in the patient a switch operableto switch from an “off” mode, in which the internal source of energy isnot in use, to an “on” mode, in which the internal source of energysupplies energy for the operation of the constriction/stimulation unit,and/or for energizing implanted electronic components of theconstriction/stimulation unit. The switch may be operated by the energyof the first form or by the energy of the second form. The describedswitch arrangement reduces power consumption of theconstriction/stimulation unit between operations.

The internal source of energy may store the energy of the second form.In this case, the internal source of energy suitably comprises anaccumulator, such as at least one capacitor or at least one rechargeablebattery, or a combination of at least one capacitor and at least onerechargeable battery. Where the internal source of energy is arechargeable battery it may be charged only at times convenient for thepatient, for example when the patient is sleeping. Alternatively, theinternal source of energy may supply energy for the operation of theconstriction/stimulation unit but not be used for storing the energy ofthe second form. In this alternative, the internal source of energy maybe a battery and the switch described above may or may not be provided.

Suitably, the method of the invention may comprise implanting astabilizer for stabilizing the energy of the second form. Where theenergy of the second form comprises electric energy the stabilizersuitably comprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Control of Constriction/Stimulation Unit

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the control of the constriction andstimulation devices combined in the constriction/stimulation unit couldbe used for the separate constriction device and separate stimulationdevice, where applicable. Although the constriction device of theconstriction/stimulation unit may normally keep the patient's wallportion in the constricted state, in most applications using the presentinvention there will be daily adjustments of the constriction device.Therefore, in a preferred embodiment of the invention, the constrictiondevice is adjustable to enable changing the constriction of thepatient's wall portion as desired and the control device controls theconstriction device to change the constriction of the wall portion.

The method of the invention suitably comprises operating the controldevice by the patient. In a simple form the control device comprises amanually operable switch for switching on and off theconstriction/stimulation unit, and the method further comprisessubcutaneously implanting the switch in the patient. It is preferable,however, that the control device comprises a hand-held wireless remotecontrol operable by the patient from outside the patient's body tocontrol the constriction/stimulation unit to adjust the stimulationintensity and/or adjust the constriction of the wall portion. Thewireless remote control is suitably designed for application on thepatient's body like a wristwatch.

In some applications of the invention, the constriction device of theconstriction/stimulation unit may be designed to normally keep thepatient's wall portion in the constricted state. I.e., afterimplantation the constriction device all the time keeps the wall portionconstricted. In this case, the control device may be used when needed,conveniently by the patient, to control the stimulation device of theconstriction/stimulation unit to stimulate the constricted tissue wallportion, preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, so that the flow in the lumen is atleast further restricted or stopped, and to control the stimulationdevice to cease the stimulation. More precisely, the method of theinvention may comprise operating the control device by the patient to

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow in the lumen andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to increase the flow in the lumen; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow in the lumen and control thestimulation device in a second mode to cease the stimulation of the wallportion to allow flow in the lumen.

Either the first mode or the second mode may be temporary.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above signals may comprise wave signals, such as a sound wavesignal, an ultrasound wave signal, an electromagnetic wave signal, aninfrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal or a gamma radiation signal.

Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

Operation of Constriction/Stimulation Unit

It should be understood that any embodiment or part of embodiment foroperating the combined stimulation device and constriction device, couldbe used, if applicable, for any one of the devices as a stand alonedevice. The method of the invention may comprise implanting in thepatient an operation device, and operating the constriction/stimulationunit with the operation device. A magnet may be provided, wherein themethod comprises using the magnet to activate the operation device fromoutside the patient's body. The operation device suitably comprises amotor which is powered with energy released from a source of energy,such as a battery. Although the constriction/stimulation unit inembodiments described above suitably is designed as a single piece,which is most practical for implantation, it should be noted that as analternative the constriction device and stimulation device of theconstriction/stimulation unit could be designed as separate pieces.

Laparoscopic Method

The present invention also provides a first method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

inserting a needle like tube into the cavity of the patients body,

filling the cavity with gas thereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the organ,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the organ,

using the constriction device to gently constrict the wall portion ofthe organ to influence the flow in the lumen, and

using the stimulation device to stimulate the constricted wall portionto cause contraction of the wall portion to further influence the flowin the lumen.

The present invention also provides a second method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the organ,

placing a stimulation device in the dissected area in operativeengagement with the organ, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the lumen.

The present invention also provides a third method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the organ,

placing a constriction device in the dissected area in operativeengagement with the organ,

using the constriction device to constrict the wall portion of the organto influence the flow in the lumen.

The present invention also provides a fourth method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the organ,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the organ,

using the constriction device to gently constrict the wall portion ofthe organ to influence the flow in the lumen, and

using the stimulation device to stimulate the constricted wall portionto cause contraction of the wall portion to further influence the flowin the lumen.

The present invention also provides a fifth method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the organ,

placing a stimulation device in the dissected area in operativeengagement with the organ, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the lumen.

The present invention also provides a sixth method for controlling aflow of fluid and/or other bodily matter in a lumen formed by a tissuewall of a patient's organ. The method comprises the steps of:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the organ,

placing a constriction device in the dissected area in operativeengagement with the organ, and

using the constriction device to constrict the wall portion of the organto influence the flow in the lumen.

In all of the above-noted methods 1-6 the cavity may constitute at leastone of an abdominal cavity, a cavity in the pelvic region, a thoraxialcavity, a cavity in a limb, a cavity in human soft tissue such asmuscle, fat and fibrotic tissue.

The method further comprises implanting a powered operation device foroperating the constriction device. The operation device may comprise apowered hydraulic operation device or an electrically powered operationdevice, such as an electric motor.

The method further comprises transmitting wireless energy for poweringthe operation device, and when desired to influence the flow in thepatient's organ, powering the operation device with the transmittedenergy to operate the constriction device.

The method further comprises implanting a source of energy in thepatient, providing an external source of energy, controlling theexternal source of energy to release wireless energy, transforming thewireless energy into storable energy, such as electric energy,non-invasively charging the implanted source of energy with thetransformed energy, and controlling the implanted source of energy fromoutside the patient's body to release energy for use in connection withthe operation of the constriction device and/or stimulation device. Thewireless energy is transformed into a storable energy different from thewireless energy.

Alternatively, the method further comprises providing a source of energyoutside the patient's body, controlling the external source of energyfrom outside the patient's body to release wireless energy, and usingthe released wireless energy for operating the constriction deviceand/or stimulation device. The wireless energy may be transformed intoelectrical energy inside the patient's body by an implantedenergy-transforming device, wherein the electrical energy is used inconnection with the operation of the constriction device and/orstimulation device. The electrical energy may be directly used inconnection with the operation of the constriction device and/orstimulation device, as the transforming device transforms the wirelessenergy into the electrical energy. The external source of energy may becontrolled from outside the patient's body to release non-magneticwireless energy, wherein the released non-magnetic wireless energy isused for operating the constriction device and/or stimulation device.Alternatively, the external source of energy may be controlled fromoutside the patient's body to release electromagnetic wireless energy,wherein the released electromagnetic wireless energy is used foroperating the constriction device and/or stimulation device.

The above-described methods of the present invention may be practisedfor treating dysfunctions of an organ of a human being or an animal.

Feed Back Related to the Wireless Energy

The following embodiments are related to feed back information relatedto an energy balance either comparing;

-   -   a) the amount of energy received by the internal energy source        compared to the energy used by the constriction device and/or        stimulation device, or    -   b) The amount of energy received by the internal energy source        and the amount of energy transmitted by the external energy        source.

Several alternatives of the method of the present invention aredisclosed below and may except being correlated directly to theconstriction device and/or stimulation device also be included in theoperating method. These methods are valid for use both with thestimulation device and constriction device separate or in combination.

A method for controlling the transmission of wireless energy comprisingan internal energy source, wherein said wireless energy is transmittedfrom an external energy source located outside the patient and isreceived by the internal energy source located inside the patient, theinternal energy source being connected to the constriction device and/orstimulation device for directly or indirectly supplying received energythereto, the method comprising the steps of:

determining an energy balance between the energy received by theinternal energy source and the energy used for the constriction deviceand/or stimulation device, and

controlling the transmission of wireless energy from the external energysource, based on the determined energy balance.

A method, wherein the wireless energy is transmitted inductively from aprimary coil in the external energy source to a secondary coil in theinternal energy receiver.

A method, wherein a change in said energy balance is detected, and thetransmission of wireless energy is controlled based on said detectedenergy balance change.

A method, wherein a difference is detected between energy received bysaid internal energy receiver and energy used for a medical device, andthe transmission of wireless energy is controlled based on said detectedenergy difference.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy balance change implies that the energy balance isincreasing, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to a detected change rate.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy difference implies that the received energy isgreater than the used energy, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to the magnitude of said detected energy difference.

A method, wherein the energy used for the constriction device and/orstimulation device is stored in at least one energy storage device ofthe device.

A method, wherein substantially all the energy used for the constrictiondevice and/or stimulation device is consumed to operate the device.

A method, wherein the energy is consumed after being stabilised in atleast one energy stabilising unit of the device.

A method, wherein the energy used for the constriction device and/orstimulation device is stored in at least one energy storage device ofthe device.

A method, wherein substantially all the energy used for the constrictiondevice and/or stimulation device i is consumed to operate the device.

A method, wherein the energy is consumed after being stabilised in atleast one energy stabilising unit of the device.

A method of controlling transmission of wireless energy supplied to atleast one of the constriction and stimulation devices, comprising aninternal energy source located inside the patient, connected to theconstriction device and/or stimulation device for directly or indirectlysupplying received energy thereto, the method comprising the steps of:

determining an energy balance between the energy sent by the externalenergy source and the energy received by the internal energy source ,and

controlling the transmission of wireless energy from the external energysource, based on the determined energy balance.

A method, wherein the wireless energy is transmitted inductively from aprimary coil in the external energy source to a secondary coil in theinternal energy receiver.

A method, wherein a change in said energy balance is detected, and thetransmission of wireless energy is controlled based on said detectedenergy balance change.

A method, wherein a difference is detected between the energy sent bythe external energy source and the energy received by said internalenergy receiver , and the transmission of wireless energy is controlledbased on said detected energy difference.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy balance change implies that the energy balance isincreasing, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to a detected change rate.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy difference implies that the received energy isgreater than the used energy, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to the magnitude of said detected energy difference.

A method of controlling transmission of wireless energy, wherein saidwireless energy being transmitted by means of a primary coil in theexternal energy source and received inductively by means of a secondarycoil in an internal energy source, the internal energy source beingconnected to the medical device for directly or indirectly supplyingreceived energy thereto, wherein feedback control information (S) istransferred from the secondary coil to the primary coil by switching thesecondary coil on and off to induce a detectable impedance loadvariation in the primary coil encoding the feedback control information,wherein the feedback control information relates to the energy receivedby the internal energy source and is used for controlling thetransmission of wireless energy from the external energy source.

285 The apparatus according to claim 284, wherein the external energysource further comprises an electronic circuit for comparing thefeedback information with the amount of energy transmitted by theexternal energy source.

The method, wherein the electronic circuit comprises an analyzeranalyzing the amount of energy being transmitted and receiving thefeedback information related to the amount of energy received in thereceiver, and determining the energy balance by comparing the amount oftransmitted energy and the feedback information related to the amount ofreceived energy.

The method, wherein the external energy source is adapted to use saidfeedback information adjusting the level of said transmitted energy.

A method of controlling transmission of wireless energy, wherein saidwireless energy being transmitted by means of a primary coil in anexternal energy source and received inductively by means of a secondarycoil in an internal energy source, the internal energy receiver beingconnected to the medical device for directly or indirectly supplyingreceived energy thereto, wherein feedback control information (S) istransferred from the secondary coil to the primary coil by switching thesecondary coil on and off to induce a detectable impedance loadvariation in the primary coil encoding the feedback control information,where the feedback control information relates to said energy balance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, 1D and 1E schematically illustrate different states ofoperation of a general embodiment of an apparatus used for practicingthe method according to the present invention.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment.

FIG. 2 is a longitudinal cross-section of an embodiment of the apparatusof FIG. 1 including a constriction device and an electric stimulationdevice.

FIG. 3 is a cross-section along line II-II in FIG. 2.

FIG. 4 is the same cross-section shown in FIG. 3 but with the apparatusin a different state of operation.

FIGS. 5A, 5B and 5C are cross-sections of the embodiment of FIG. 2showing different states of operations with the apparatus applied on atissue wall of a patient's organ.

FIGS. 6A, 6B and 6C are cross-sections of a modification of theembodiment of FIG. 2 showing different states of operations with theapparatus applied on a tissue wall of a patient's organ.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the apparatus is constrictinga tissue wall of a patient's organ.

FIG. 8A is a pulse/time diagram showing electric stimulation pulsesgenerated by the apparatus used for practicing the method of theinvention, wherein the electric pulses are for stimulating a tissue wallof a patient's organ.

FIG. 8B is pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A, in which pulses of mixed frequenciesand/or amplitudes are employed.

FIGS. 9A and 9B show two pulse/time diagrams, respectively, representingelectric stimulation of two different areas of the tissue wall withpulses forming pulse trains.

FIGS. 10A and 10B show the pulse/time diagrams of FIGS. 9A and 9B withmodified pulse trains.

FIG. 11A is a longitudinal cross-section of an embodiment of anapparatus used for practicing the method of the invention, where theapparatus includes a thermal stimulation device and the apparatus isconstricting a tissue wall of a patient's organ.

FIG. 11B is the same embodiment of FIG. 11A with the thermal stimulationdevice activated.

FIG. 12A is a schematic view of hydraulic operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 12B shows the embodiment of FIG. 12A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13A is a schematic view of mechanical operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 13B shows the embodiment of FIG. 13A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13C shows a modification of the embodiment of FIG. 13B.

FIGS. 14A to 14D illustrate an apparatus for use with the methodaccording to the invention when implanted in a male patient forcontraception.

FIG. 15 is a schematic sectional view of a mechanically operablenon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 16 and 17 are cross-sectional views taken along the lines XVI-XVIand XVII-XVII, respectively, of FIG. 15.

FIG. 18 schematically shows an alternative design of the embodiment ofFIG. 15;

FIG. 19 schematically illustrates a motor arrangement for the embodimentaccording to FIG. 18;

FIGS. 20 and 21 are schematic sectional views of two alternative designsof non-inflatable constriction devices used for practicing the method ofthe invention.

FIGS. 22 and 23 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 21;

FIG. 24 is a schematic view of a further alternative design of anon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 25 and 26 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 24;

FIG. 27 is a schematic view of another alternative design of anon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 28 and 29 are schematic sectional views, respectively, of yetanother alternative design of a non-inflatable constriction device usedfor practicing the method of the invention.

FIG. 30A is a schematic view of a hydraulically operable inflatableconstriction device for used for practicing the method of the invention.

FIG. 30B is the same embodiment shown in FIG. 30A with the constrictiondevice inflated.

FIGS. 31A, 31B, 31C and 31D are block diagrams illustrating fourdifferent principles for hydraulic operation of the constriction deviceshown in FIG. 30A.

FIG. 32 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor.

FIGS. 33A and 33B are perspective views of a reverse servo in accordancewith a particular embodiment of the hydraulic operation principle shownin FIG. 31C.

FIG. 34 is a schematic view of another hydraulically operableconstriction device for practicing the method according to the presentinvention.

FIG. 35A illustrates the constriction device of FIG. 34 in a constrictedstate.

FIG. 35B illustrates the constriction device of FIG. 34 in a releasedstate.

FIGS. 36A-36E schematically illustrate different operation stages of anembodiment of the invention, in which a constriction device and astimulation device used for practicing the method of the inventionco-operate to move the fluid and/or other bodily matter in the lumen ofa patient's organ.

FIGS. 37 to 49 are schematic block diagrams illustrating twelveembodiments, respectively, of an apparatus used for practicing themethod of the invention, wherein wireless energy is transmitted fromoutside a patient's body to energy consuming components of the apparatusimplanted in the patient.

FIG. 50 illustrates an energy-transforming device in the form of anelectrical junction element used for practicing the method of theinvention.

FIG. 51 is a block diagram illustrating control components used forpracticing the method of the invention.

FIG. 52 is a schematic view of exemplary circuitry of an embodiment ofthe invention, in which wireless energy is transformed into a current.

FIGS. 53A-53C schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIG. 2 used forpracticing the method of the invention, wherein a constriction deviceand a stimulation device co-operate to move the fluid and/or otherbodily matter in the lumen of a patient's organ.

FIGS. 54A-54B schematically illustrate different operation stages ofanother apparatus of the type shown in FIGS. 36A-36E used for practicingthe method of the invention, wherein a constriction device and astimulation device co-operate to move the fluid and/or other bodilymatter in the lumen of a patient's organ.

FIG. 55A is a schematic view of another mechanically operablenon-inflatable constriction device used for practicing the method of theinvention.

FIG. 55B shows the constriction device of FIG. 55A in a constrictedstate.

FIG. 55C is an end view of the embodiment of FIG. 55B. FIG. 56 is aschematic block diagram illustrating an arrangement for supplying anaccurate amount of wireless energy used for the operation of theconstriction/stimulation unit as described above.

FIG. 57 schematically shows an embodiment of the invention, in which theapparatus is operated with wire bound energy.

FIG. 58 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 59 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIG. 60 is a sectional view through a constriction device.

FIG. 61A-C illustrates the constriction device of FIG. 60 in differentinterrupting stages.

FIG. 62A-D show a second embodiment of a constriction device.

FIG. 63A-E disclose one particular embodiment of the invention usingpump to such bodily matter in the lumenal organ.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1A, 1B and 1C schematically illustrate different states ofoperation of a generally designed apparatus used for practicing themethod of the present invention, when the apparatus is applied on a wallportion of a bodily organ designated BO. The apparatus includes aconstriction device and a stimulation device, which are designated CSD,and a control device designated CD for controlling the constriction andstimulation devices CSD. FIG. 1A shows the apparatus in an inactivationstate, in which the constriction device does not constrict the organ BOand the stimulation device does not stimulate the organ BO. FIG. 1Bshows the apparatus in a constriction state, in which the control deviceCD controls the constriction device to gently constrict the wall portionof the organ BO to a constricted state, in which the blood circulationin the constricted wall portion is substantially unrestricted and theflow in the lumen of the wall portion is restricted. FIG. 10 shows theapparatus in a stimulation state, in which the control device CDcontrols the stimulation device to stimulate different areas of theconstricted wall portion, so that the wall portion of the organ BOcontracts (thickens) and closes the lumen.

FIGS. 1D and 1E show how the stimulation of the constricted wall portioncan be cyclically varied between a first stimulation mode, in which theleft area of the wall portion (see FIG. 1D) is stimulated while theright area of the wall portion is not stimulated, and a secondstimulation mode, in which the right area of the wall portion (see FIG.1E) is stimulated while the left area of the wall portion is notstimulated, in order to maintain over time satisfactory bloodcirculation in the constricted wall portion.

It should be noted that the stimulation modes shown in FIGS. 1D and 1Eonly constitute a principle example of how the constricted wall portionof the organ BO may be stimulated. Thus, more than two different areasof the constricted wall portion may be simultaneously stimulated incycles or successively stimulated. Also, groups of different areas ofthe constricted wall portion may be successively stimulated.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment shown in FIGS. 1A-1E, wherein theconstriction and stimulation devices CSD include several separateconstriction/stimulation elements, here three elements CSDE1, CSDE2 andCSDE3. FIG. 1F shows how the element CSDE1 in a first state of operationis activated to both constrict and stimulate the organ BO, so that thelumen of the organ BO is closed, whereas the other two elements CSDE2and CSDE3 are inactivated. FIG. 1G shows how the element CSDE2 in asecond following state of operation is activated, so that the lumen ofthe organ BO is closed, whereas the other two elements CSDE1 and CSDE3are inactivated. FIG. 1H shows how the element CSDE3 in a followingthird state of operation is activated, so that the lumen of the organ BOis closed, whereas the other two elements CSDE1 and CSDE2 areinactivated. By shifting between the first, second and third states ofoperation, either randomly or in accordance with a predeterminedsequence, different portions of the organ can by temporarily constrictedand stimulated while maintaining the lumen of the organ closed, wherebythe risk of injuring the organ is minimized. It is also possible toactivate the elements CSDE1-CSDE3 successively along the lumen of theorgan to move fluids and/or other bodily matter in the lumen.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment. Thus, FIG. 1I shows how theelement CSDE1 in a first state of operation is activated to bothconstrict and stimulate the organ BO, so that the lumen of the organ BOis closed, whereas the other two elements CSDE2 and CSDE3 are activatedto constrict but not stimulate the organ BO, so that the lumen of theorgan BO is not completely closed where the elements CSDE2 and CSDE3engage the organ BO. FIG. 1K shows how the element CSDE2 in a secondfollowing state of operation is activated to both constrict andstimulate the organ BO, so that the lumen of the organ BO is closed,whereas the other two elements CSDE1 and CSDE3 are activated toconstrict but not stimulate the organ BO, so that the lumen of the organBO is not completely closed where the elements CSDE1 and CSDE3 engagethe organ BO. FIG. 1L shows how the element CSDE3 in a following thirdstate of operation is activated to both constrict and stimulate theorgan BO, so that the lumen of the organ BO is closed, whereas the othertwo elements CSDE1 and CSDE2 are activated to constrict but notstimulate the organ BO, so that the lumen of the organ BO is notcompletely closed where the elements CSDE1 and CSDE2 engage the organBO. By shifting between the first, second and third states of operation,either randomly or in accordance with a predetermined sequence,different portions of the organ can by temporarily stimulated whilemaintaining the lumen of the organ closed, whereby the risk of injuringthe organ is reduced. It is also possible to activate the stimulation ofthe elements CSDE1-CSDE3 successively along the lumen of the organ BO tomove fluids and/or other bodily matter in the lumen.

FIGS. 2-4 show basic components of an embodiment of the apparatusaccording to FIGS. 1A-1C for controlling a flow of fluid and/or otherbodily matter in a lumen formed by a tissue wall of a patient's organ.The apparatus includes a tubular housing 1 with open ends, aconstriction device 2 arranged in the housing 1, a stimulation device 3integrated in the constriction device 2, and a control device 4(indicated in FIG. 4) for controlling the constriction and stimulationdevices 2 and 3. The constriction device 2 has two elongate clampingelements 5, 6, which are radially movable in the tubular housing 1towards and away from each other between retracted positions, see FIG.3, and clamping positions, see FIG. 4. The stimulation device 3 includesa multiplicity of electrical elements 7 positioned on the clampingelements 5, 6, so that the electrical elements 7 on one of the clampingelements 5, 6 face the electrical elements 7 on the other clampingelement. Thus, in this embodiment the constriction and stimulationdevices form a constriction/stimulation unit, in which the constrictionand stimulation devices are integrated in a single piece.

The constriction and stimulation devices may also be separate from eachother. In this case, a structure may be provided for holding theelectrical elements 7 in a fixed orientation relative to one another.Alternatively, the electrical elements 7 may include electrodes that areseparately attached to the wall portion of the patient's organ.

FIGS. 5A-5C illustrate in principle the function of the apparatus ofFIG. 2 when the apparatus is applied on a portion 8 of a tubular tissuewall of a patient's organ. Thus, FIG. 5A shows the apparatus in anon-clamping state, in which the clamping elements 5, 6 are in theirretracted positions and the wall portion 8 extends through the open endsof the housing 1 without being constricted by the clamping elements 5,6. FIG. 5B shows the apparatus in a clamping state, in which theclamping elements 5, 6 have been moved from their retracted positions totheir clamping positions, in which the clamping elements 5, 6 gentlyconstrict the wall portion 8 to a constricted state, in which the bloodcirculation in the constricted wall portion 8 is substantiallyunrestricted and the flow in the lumen of the wall portion 8 isrestricted. FIG. 5C shows the apparatus in a stimulation state, in whichthe clamping elements 5, 6 constrict the wall portion 8 and theelectrical elements 7 of the stimulation device 3 electrically stimulatedifferent areas of the wall portion 8, so that the wall portion 8contracts (thickens) and closes the lumen.

When the apparatus is in its stimulation state, it is important tostimulate the different areas of the wall portion 8 in a manner so thatthey essentially maintains their natural physical properties over timeto prevent the areas from being injured. Consequently, the controldevice 4 controls the stimulation device 3 to intermittently stimulateeach area of the wall portion 8 during successive time periods, whereineach time period is short enough to maintain over time satisfactoryblood circulation in the area. Furthermore, the control device 4controls the stimulation of the areas of the wall portion 8, so thateach area that currently is not stimulated restores substantially normalblood circulation before it is stimulated again. To maintain over timethe effect of stimulation, i.e., to keep the lumen closed by maintainingthe wall portion 8 contracted, the control device 4 controls thestimulation device 3 to stimulate one or more of the areas at a time andto shift the stimulation from one area to another over time. The controldevice 4 may control the stimulation device 3 to cyclically propagatethe stimulation of the areas along the tubular wall portion 8, forexample in accordance with a determined stimulation pattern. To achievethe desired reaction of the tissue wall during the stimulation thereof,the control device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion 8.

In the embodiment of FIGS. 2-4, the electrical elements 7 form a seriesof fourteen groups of electrical elements 7 extending longitudinallyalong each elongate clamping element 5 and 6, respectively, see FIG. 2.The electrical elements 7 of each group of electrical elements 7 form afirst path of four electrical elements 7 positioned in a row on clampingelement 5 and extending tranverse thereto and a second path of fourelectrical elements 7 positioned in a row on clamping element 6 andextending tranverse thereto. Thus, the two paths of electrical elements7 extend on mutual sides of the patient's organ. The control device 4controls the stimulation device 3 to successively energize the groups ofelectrical elements 7 in the series of groups in a direction opposite toor, alternatively, in the same direction as that of the flow in thepatient's lumen. Of course, the number of electrical elements 7 of eachpath of electrical elements 7 can be greater or smaller than four, andseveral parallel rows electrical elements 7 can form each path ofelectrical elements 7.

FIGS. 6A-6C show another embodiment of an apparatus used for practicingthe method of the invention including a tubular housing 9 and threeelongate clamping elements 10 a, 10 b, 10 c, which are radially movablein the tubular housing 9 towards and away from a central axis thereofbetween retracted positions, see FIG. 6A, and clamping positions, seeFIG. 6B. The three clamping elements 10 a-10 c are symmetricallydisposed around the central axis of the housing 9. The stimulationdevice of this embodiment includes electrical elements 11 a, 11 b, 11 cthat form a series of groups of elements extending longitudinally alongthe elongate clamping elements 10 a-10 c, wherein the electricalelements 11 a-11 c of each group of electrical elements form a path ofthree electrical elements 11 a, 11 b and 11 c extendingcircumferentially around the central axis of the housing 9. The threeelectrical elements 11 a-11 c of each group are positioned on the threeclamping elements 10 a-10 c, respectively. Thus, the path of threeelectrical elements 11 a-11 c extends around the patient's organ. Ofcourse, the number of electrical elements 11 a-11 c of each path ofelectrical elements can be greater than three, and several parallel rowselectrical elements 11 a-11 c can form each path of electrical elements.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the clamping elements 5, 6 ofthe apparatus are constricting a portion of a tubular tissue wall of apatient's organ 12 to restrict the flow in the lumen 13 of the organ 12.For the sake of clarity only the clamping elements 5, 6 of theconstriction device 2 are shown in FIGS. 7A, 7B. Thus, FIG. 7Aillustrates how energized electrical elements 7 of groups of electricalelements electrically stimulate a first portion 14 and a second portion15 of the tubular wall to contract and close the lumen 13. FIG. 7Billustrates how energized electrical elements 7 of other groups ofelectrical elements electrically stimulate a third portion 16 of thetubular wall different from the first and second portions to contractand close the lumen 13, while the electrical stimulation of the firstand second portions 14, 15 of the tubular wall has been ceased, so thatsubstantially normal blood circulation in the first and second portionsis restored. In this manner, the electric stimulation of the constrictedtubular wall is shifted over time from one portion of the tubular wallto another to insure recurrent restoration of blood circulation in theconstricted tubular wall.

The control device 4 controls the stimulation device 3 to energize theelectrical elements 7 with electric biphasic pulses, i.e., combinedpositive and negative pulses. The desired stimulation effect is achievedby varying different pulse parameters. Thus, the control device 4controls the stimulation device 3 to vary the pulse amplitude (voltage),the off time period between successive pulses, the pulse duration andthe pulse repetition frequency. The pulse current should be between 1 to30 mA. For neural stimulation, a pulse current of about 5 mA and a pulseduration of about 300 μs are suitable, whereas a pulse current of about20 mA and a pulse duration of about 30 μs are suitable for muscularstimulation. The pulse repetition frequency suitably is about 10 Hz. Forexample, as illustrated in the Pulse/time diagram P/t of FIG. 8A, apulse combination including a negative pulse PS of short duration andhigh amplitude (voltage), and a positive pulse PL of long duration andlow amplitude following the negative pulse may be cyclically repeated toform a pulse train of such pulse combinations. The energy content of thenegative pulse PS should be substantially equal to the energy content ofthe positive pulse PL.

FIG. 8B is a pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A. Thus, the pulse combination of FIG. 8A ismixed with a pulse train combination having a first relatively longpulse train PTL of high frequency/low amplitude pulses, appearingsimultaneously with the positive pulse PL of the pulse combination ofFIG. 8A, and a second relatively short pulse train PTS of highfrequency/low amplitude appearing simultaneously with the negative pulsePS of the pulse combination shown in FIG. 8A. As a result, the highfrequency/low amplitudes pulse trains PTL and PTS are superimposed onthe positive and negative pulses PL and PS of FIG. 8A, as illustrated inFIG. 8B. The pulse configuration of FIG. 8B, and variations thereof, isbeneficial to use in connection with the stimulation of particular humanorgans, in order to achieve the desired stimulation effect.

Preferably, the electric pulses form pulse trains, as illustrated in thePulse/time diagrams P/t of FIGS. 9A, 9B, 9C and 9D. The Pulse/timediagram P/t of FIG. 9A represents an individual area of the wall portionof the patient's tubular organ which is stimulated with a pulse train18A. The pulse train 18A includes three initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the negativepulses. After a delay to enable the area of the organ to restoresubstantially normal blood circulation the pulse train 18A is repeated.

The Pulse/time diagram P/t of FIG. 9B represents another individual areaof the wall portion, which is stimulated with a pulse train 18B havingthe same configuration as the pulse train 18A. The pulse trains 18A and18B are shifted relative to each other, so that they partially overlapone another to ensure that the constricted wall portion always isstimulated to contract as desired.

The pulse/time diagrams P/t of FIGS. 10A and 10B represent two differentareas of the wall portion, which are stimulated with cyclically repeatedpulse trains 18C and 18D, respectively, having the same configuration.Each pulse train 18C, 18D includes two initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the twonegative pulses. In this case, the pulse trains 18C and 18D are shiftedrelative to each other, so that they do not overlap each other. Thus,the off time period between adjacent pulse trains 18C is longer than theduration of pulse train 18D and the off time period between adjacentpulse trains 18D is longer than the duration of pulse train 18C.

The pulse trains 18A, 18B, 18C and 18D can be configured in manydifferent ways. Thus, the control device 4 can control the stimulationdevice 2 to vary the length of each pulse train, the repetitionfrequency of the pulse trains, the number of pulses of each pulse train,and/or the off time periods between the pulse trains. Typically, thecontrol device 4 controls each off time period between the pulse trainsto last long enough to restore substantially normal blood circulation inthe area that just has been stimulated before that area again isstimulated with electric pulses.

FIGS. 11A and 11B show another embodiment of an apparatus used forpracticing the method of the invention that controls blood flow in ablood vessel 19. The apparatus of FIGS. 11A and 11B includes aconstriction device with two clamping elements 20 a and 20 b, astimulation device in the form of two thermal stimulation elements 21 aand 21 b integrated in the clamping elements 20 a, 20 b, respectively,and a control device 4 for controlling the clamping elements 20 a, 20 band stimulation elements 21 a, 21 b. The clamping elements 20 a and 20 bare movable towards and away from each other in the same manner asdescribed above in connection with the embodiment according to FIGS.5A-5C. The thermal stimulation elements 21 a and 21 b, which may includePertier elements, are positioned on the clamping elements 20 a, 20 b, sothat the thermal elements 21 a are facing the thermal elements 21 b.FIG. 11A shows how the clamping elements 20 a, 20 b constrict the bloodvessel 19, so that the blood flow is restricted. FIG. 11B shows how thecontrol device 4 controls the thermal stimulation elements 21 a, 21 b tocool the wall of the blood vessel 19, so that the wall contracts andcloses the blood vessel 19. To release the blood vessel 19, the controldevice 4 controls the thermal stimulation elements 21 a, 21 b to heatthe wall of the blood vessel 19, so that the wall expands.

FIGS. 12A and 12B show hydraulic operation means suited for operatingthe constriction device of the embodiments described above.Specifically, FIGS. 12A and 12B show the apparatus of FIG. 2 providedwith such means for hydraulic operation of the constriction device 2.(The stimulation device is not shown.) Thus, the housing 1 forms twohydraulic chambers 22 a and 22 b, in which the two clamping elements 5,6are slidable back and forth relative to the tubular tissue wall portion8 of a patient's organ. The hydraulic operation means include anexpandable reservoir 23, such as an elastic balloon, containinghydraulic fluid, conduits 24 a and 24 b between the reservoir 23 and thehydraulic chambers 22 a, 22 b, and a two-way pump 25 for pumping thehydraulic fluid in the conduits 24 a, 24 b. The control device 4controls the pump 25 to pump hydraulic fluid from the reservoir 23 tothe chambers 22 a, 22 b to move the clamping elements 5, 6 against thewall portion 8, whereby the tubular wall portion 8 is constricted, seeFIG. 12B, and to pump hydraulic fluid from the chambers 22 a, 22 b tothe reservoir 23 to move the clamping elements 5, 6 away from the wallportion 8, whereby the tubular wall 8 is released, see FIG. 12A.

Alternatively, the embodiment of FIGS. 12A and 12B may be manuallyoperated by applying suitable manually operable hydraulic means fordistributing the hydraulic fluid between the expandable reservoir 23 andthe hydraulic chambers 22 a, 22 b. In this case the pump 25 is omitted.

FIGS. 13A and 13B schematically show another embodiment of an apparatusused for practicing the method of the invention. The apparatus of FIGS.13A and 13B comprises an open ended tubular housing 26 applied on thetubular tissue wall portion 8 of a patient's organ, a constrictiondevice 27 arranged in the housing 26 and a control device 4 forcontrolling the constriction device 27. A stimulation device (not shown)as described above is also provided in the housing 26. The constrictiondevice 27 includes a clamping element 28, which is radially movable inthe tubular housing 26 towards and away from the tubular wall portion 8between a retracted position, see FIG. 13A, and a clamping position, seeFIG. 13B, in which the clamping element 28 gently constricts the tubularwall portion 8. Mechanical operation means for mechanically operatingthe clamping element 28 includes an electric motor 29 attached to thehousing 26 and a telescopic device 30, which is driven by the motor 29and operatively connected to the clamping element 28. The control device4 controls the electric motor 29 to expand the telescopic device 30 tomove the clamping element 28 against the wall portion 8, whereby thetubular wall portion 8 is constricted, see FIG. 13B, and controls themotor 29 to retract the telescopic device 30 to move the clampingelement 28 away from the wall portion 8, whereby the wall portion 8 isreleased, see FIG. 13A.

Alternatively, the motor 29 may be omitted and the telescopic device 30be modified for manual operation, as shown in FIG. 13C. Thus, a spring30 a may be provided acting to keep the telescopic device 30 expanded toforce the clamping element 28 against the wall portion 8. The mechanicaloperation means may include a subcutaneously implanted lever mechanism29 a that is operatively connected to the telescopic device 30. Thepatient may push the lever mechanism 29 a through the skin to pull thetelescopic device 30 against the action of the spring 30 a to theretracted position of the telescopic device 30, as indicated in phantomlines. When the patient releases the lever mechanism 29 a, the spring 30a expands the telescopic device 30, whereby clamping element 28 isforced against the wall portion 8.

The mechanical operation means as described above in connection withFIGS. 13A, 13B and 13C may also be implemented in the embodimentsaccording to FIGS. 1-11.

FIG. 14A illustrates the embodiment of FIG. 2 applied on vas deferensfor male contraception. With reference to FIGS. 14A and 14B an apparatusfor male contraception is now described. FIG. 14A shows a restriction ofvas deferens (vasa deferentia) with the controller. FIG. 14B depictsonly the restriction devices of the invention. FIG. 14A shows theapparatus having with two restriction devices 660A and 660B inarrangement with the two vas deferens to perform restriction of theselumens to prevent from that sperms are transported through the vasdeferens. Restriction devices 660A and 660B operates both to constrictand to stimulate vas deferens. The restriction devices are operativelyconnected to the controller 600 having a control device 650 that issubcutaneously implanted. The control device has an energy source 651for supplying energy consuming parts of the apparatus with energy. Theenergy source is supplied with wireless energy from an externalenergizer unit 620. The controller further includes an external remotecontrol unit 630 capable of communicating with the control device 650and an internal control unit 640. The control device further has anexternal part 652 for including functions needed for external operationsuch as an injection port for supply of hydraulic fluid when theconstriction is hydraulically operated and an activation/deactivationbutton for operating the restriction. FIG. 14C shows the same apparatusas in FIG. 14B without the control device. FIG. 14D shows a manuallyoperated embodiment of the contraception device. A manually operablepump 670 located in the scrotum hydraulically operates on therestriction device 660A to restrict vas deferens.

FIGS. 15-17 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 15-17 includes amechanically operable constriction device having an elongatedconstriction member in the form of a circular resilient core 37 with twooverlapping end portions 38,39. The core 37 defines a substantiallycircular restriction opening and is enclosed in an elastic soft hose 40except at a releasable and lockable joint 41 of the core 37, which whenreleased enables application of the core 37 with its hose 40 around aportion of a tubular tissue wall of a patient. The materials of all ofthese elements are bio-compatible so that the patient' body will notreject them. An operation device 42 for mechanically operating thelongitudinal extension of the core 37 to change the size of therestriction opening comprises a drive wheel 43 in frictional engagementwith the overlapping end portions 38,39 of the core 37. The drive wheel43 is journalled on a holder 44 placed in the hose 40 and provided withtwo counter pressure rollers 45,46 pressing the respective end portions38, 39 of the core 37 against the drive wheel 43 to increase thefrictional engagement there between. An electric motor 47 of theoperation device is connected to the drive wheel 43 via a long flexibledrive shaft 48 and is moulded together with a remote controlled powersupply unit 49 in a body 50 of silicone rubber. The length of theflexible drive shaft 48 is selected so that the body 50 can be placed ina desired position in the patient's body, suitably in the abdomen.

The power supply unit 49 can be controlled to power the electric motor47 to turn the drive wheel 43 in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or to turn thedrive wheel 43 in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

In accordance with a first alternative, a rack gear may be formed on oneof the end portions 38,39 of the core 37 and the drive wheel 43 may bereplaced by a drive gear wheel connected to the other end portion of thecore 37 and in mesh with the rack gear.

In accordance with a second alternative, the operation device 42 may bedesigned as a worm-driven hose clamp, i. e., one of the end portions 38,39 of the core 37 may be provided with threads and the other end portionof the core 37 may be provided with a worm, the threads of whichinteracts with the threads of said one end portion of the core 37. Thethreads of such a worm may also interact with threads provided on bothend portions 38, 39 of the core 37.. In this alternative, the electricmotor 47 turns the worm in one direction to reduce the diameter of thecore 37, so that the wall portion is constricted, or turn the worm inthe opposite direction to increase the diameter of the core 37, so thatthe wall portion is released in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or turns theclamping screw in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

FIG. 18 shows a constriction device which is identical to theconstriction device shown in FIGS. 15-17, except that the motor 47 isencapsulated in the hose 40 so that it is fixed to the core 37 and has ashort drive shaft 51, and that the motor 47 is positioned relative tothe core 37 such that the drive shaft 51 extends substantiallytangentially to the circular core 37. There is an angular gearing 52connecting the drive shaft 51 to the drive wheel 43.

FIG. 19 shows a suitable alternative arrangement for the motor 47 in theembodiment of FIG. 17, comprising a first clamping member 53 secured toone end portion of the core 37 and a second clamping member 54 securedto the other end portion 39 of the core 37. The motor 47 is secured tothe first clamping member 53 and is operatively connected to a worm 55via a gear transmission 56. The worm 55 is journalled at its oppositeends on holders 57 and 58, which are rigidly secured to the clampingmember 53 and the motor 47, respectively. The second clamping member 54has a pinion in mesh with the worm 55. When the motor 47 is powered theworm 55 rotates and will thereby pull the end portion 39 of the core 37in one or the opposite longitudinal direction, so that the diameter ofthe substantially circular core 37 is either increased or decreased. Themotor 47, worm gear 55, gear transmission 56 and second clamping member54 constitute a servo system of the type that transfers a weak forceacting on a moving element having a long stroke into a strong forceacting on another moving element having a short stroke.

FIG. 20 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 20 includes aconstriction device having a plurality of arcuate lamellae 59 arrangedlike the conventional adjustable aperture mechanism of a camera. A motor60 operates the lamellae 59 to change the size of a restriction openingdefined by the lamellae 59.

FIGS. 21-23 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 21-23 includes aconstriction device having two semi-circular elements 61 and 62, whichare hinged together. The semi-circular elements 61,62 are swingablerelative to each other between a fully open state in which theysubstantially form a circle, illustrated in FIG. 23 and an angularstate, in which the size of the restriction opening defined by thesemi-circular elements 61, 62 is reduced, illustrated in FIG. 24. Amotor 63 operates the semi-circular elements 61, 62 to swing themrelative to each other.

FIGS. 24-28 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 24-28 includes aconstriction device having an elastic belt 64, which forms a circle andhas a substantially oval cross-section. A motor 67 operates the belt 64to turn around the longitudinal extension thereof between a fully openstate, in which the inner broader side of the belt 64 forms asubstantially cylindrical surface, illustrated in FIG. 25, and a reducedopen state, in which the inner broader side of the belt 64 forms asubstantially conical surface, illustrated in FIG. 26.

FIG. 27 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 27 includes aconstriction device 68 having two rigid articulated clamping elements 69positioned on opposite sides of a portion of a tubular tissue wall 70 ofa patient. An operation device 71 turns the clamping elements 69 towardeach other to clamp the wall portion 70 between the clamping elements 69to thereby contract the wall portion, and turns the clamping elements 69away from each other to release the wall portion from the clampingelements 69.

FIGS. 28 and 29 show another embodiment of an apparatus used forpracticing the method of the invention. The apparatus of FIGS. 28 and 29include a constriction device 300 having three bending members 301, 302and 303 displaced relative to one another in a row along a portion of atubular tissue wall 304 of a patient's organ and positioned alternatelyon opposite sides of the tubular wall 304. (Alternatively, each member301, 302 and 303 may take the shape of an hour-glass.) An operationdevice (not shown) moves the two outer members 301, 303 laterallyagainst the tubular wall 304 in one direction and the intermediatemember 302 against the tubular wall 304 in the opposite direction tobend the tubular wall 304 to thereby constrict the tubular wall portion304, see FIG. 29. To release the wall portion 304 the operation devicemoves the members 301-303 away from the tubular wall portion 304 to theposition shown in FIG. 28.

FIGS. 30A and 30B show another embodiment of an apparatus used forpracticing the method of the invention. The apparatus of FIGS. 30A and30B include a hydraulically operable elongated constriction device inthe form of a band 72 having an expandable/contractible cavity 73, whichis in fluid communication with an adjustable reservoir 74 containinghydraulic fluid. FIG. 30A illustrates when the band is in anon-constriction state, whereas FIG. 30B illustrates when the band is ina constriction state, in which the cavity 73 is expanded by hydraulicfluid supplied by the reservoir 74.

FIGS. 31A, 31B, 31C and 31D are block diagrams of three differentlyoperated hydraulic constriction devices used for practicing the methodof the invention. FIG. 31A shows the band 72 of FIG. 30A, the cavity 73of which is in fluid communication with a reservoir 75. FIG. 31B showsthe embodiment of FIG. 30A, in which the cavity 73 of the band 72 is influid communication with the reservoir 74 via an operation device in theform of a two-way pump 76. FIG. 31C shows an operation device in theform of a reverse servo system with a first closed system controlling asecond system. The reverse servo system comprises an adjustable fluidsupply reservoir 77 and an adjustable servo reservoir 78. The servoreservoir 78 controls a larger adjustable reservoir 79 which inconnection with the band 72 applied around a portion of tubular tissuewall of a patient's organ varies the volume of the cavity 73 of the band72, which in turn varies the constriction of the wall portion. FIG. 31Dshows an embodiment identical to the embodiment of FIG. 31C, except thatthe larger reservoir 79 is omitted. Instead, the servo reservoir 78 isin fluid communication with the cavity of the band 72.

In all of the above embodiments according to FIGS. 12A through 30B,stimulation devices may be provided to form constriction/stimulationunits, in which the stimulation devices include a multiplicity ofelectrical elements 7 (indicated in FIGS. 12A-15, 18, 20-23, 26-31B)positioned on the constriction devices.

FIG. 32 is a cross-sectional view of a fluid supply device including abellows reservoir 80 defining a chamber 81, the size of which isvariable by an operation device comprising a remote controlled electricmotor 82. The reservoir 80 and the motor 82 are placed in a housing 83.Moving a large wall 84 varies the chamber 81. The wall 84 is secured toa nut 85, which is threaded on a rotatable spindle 86. The spindle 86 isrotated by the motor 82. A battery 89 placed in the housing 83 powersthe motor 82. A signal receiver 90 for controlling the motor 82 is alsoplaced in the housing 83. Alternatively, the battery 89 and the signalreceiver 90 may be mounted in a separate place. The motor 82 may also bepowered with energy transferred from transmitted signals.

Where applicable, the fluid supply device of FIG. 32 may be used forsupplying hydraulic fluid for the operation of the constriction devicesdescribed in this specification. For example, the fluid supply device ofFIG. 32 may be substituted for the reservoir 74 in the embodimentaccording to FIG. 30A.

FIGS. 33A and 33B show a reverse servo used for practicing the method ofthe invention. The reverse servo includes a rectangular housing 91 andan intermediate wall 92, which is movable in the housing 91. Arelatively large, substantially cylindrical bellows reservoir 93 isarranged in the housing 91 and is joined to the movable intermediatewall 92. Another cylindrical bellows reservoir 94, which issubstantially smaller than reservoir 93, is arranged in the housing 91at the other side of the intermediate wall 92 and is also joined to thewall 92. The small bellows reservoir 94 has a fluid supply pipe 95 andthe large bellows reservoir 93 has a fluid supply pipe 96.

Referring to FIG. 33A, when a small amount of hydraulic fluid isconducted through the supply pipe 95 into the small bellows reservoir94, the small bellows reservoir 94 expands and pushes the movableintermediate wall 92 towards the large bellows reservoir 93. As aresult, the large bellows reservoir 93 is contracted by the intermediatewall 92, whereby a large amount of hydraulic fluid is forced out of thelarge bellows reservoir 93 through the supply pipe 96, see FIG. 33B.

For example, the reverse servo of FIGS. 33A and 33B may be used in theembodiment of FIG. 31 c, wherein the small bellows reservoir 94corresponds to the small servo reservoir 78 and the large bellowsreservoir 93 corresponds to the large reservoir 79. Also, the reverseservo of FIGS. 33A and 33B may be used in the embodiment of FIGS. 30Aand 30B, wherein the small bellows reservoir 94 is connected to theadjustable reservoir 74 and the large bellows reservoir 93 is connectedto the cavity 73 of the band 72.

FIG. 34 schematically shows a hydraulically operable constriction device97, which is similar to the embodiment shown in FIG. 30A, except thatthe hydraulic system is designed differently. Thus, the constrictiondevice 97 includes a relatively small inflatable cavity 98, which is influid communication with a reservoir 99 containing hydraulic fluid, anda relatively large cavity 100, which is displaceable by small cavity 98.Small cavity 98 is adapted to displace large cavity 100 to constrict thepatient's tubular wall portion when small cavity 98 is inflated and todisplace large cavity 100 to release the wall portion when small cavity98 is deflated. Thus, a relatively small addition of hydraulic fluidfrom reservoir 99 to small cavity 98 causes a relatively large increasein the constriction of the wall portion.

Large cavity 100 is defined by a contraction element in the form of abig balloon 101, which may be connected to an injection port (not shown)for calibration of the volume of large cavity 100. Adding fluid to orwithdrawing fluid from the injection port with the aid of a syringecalibrates the volume of balloon 101. Small cavity 98 is defined by asmall bellows 102 attached to an annular frame 103 of constrictiondevice 97 and at the opposite end is attached to balloon 101.

FIGS. 35A and 35B schematically illustrate the operation of constrictiondevice 97, when annular frame 103 is applied around the tubular wallportion of the patient's organ. Referring to FIG. 35A, when small cavity98 is deflated bellows 102 pulls balloon 101 inwardly into annular frame103, so that constriction device 97 constricts the wall portion.Referring to FIG. 34B, when small cavity 98 is inflated bellows 102pulls balloon 101 out of annular frame 103, so that constriction device97 releases the wall portion.

As mentioned above, the constriction device and stimulation device canco-operate to actively move the fluid and/or other bodily matter in thelumen of a patient's organ. This can be practised by use of theconstriction/stimulation unit according to FIG. 2. Thus, in accordancewith a first cooperation option, the clamping elements 5, 6 of theconstriction device constricts the wall portion 8 without completelyclosing the lumen, and the control device 4 controls the electricalelements 7 to progressively stimulate the constricted wall portion inthe downstream or upstream direction of the lumen to cause progressivecontraction of the wall portion 8 to move the fluid and/or other bodilymatter in the lumen.

In accordance with a second cooperation option, the constriction deviceconstricts the wall portion so that the flow in the lumen is restricted,and the control device 4 controls a few electrical elements 7 at one endof the elongate clamping elements 5, 6 to stimulate the constricted wallportion 8 to close the lumen either at an upstream end or a downstreamend of the wall portion 8. With the lumen closed in this manner, thecontrol device 4 controls the constriction device to increase theconstriction of the wall portion, whereby the fluid and/or other bodilymatter in the lumen is moved downstream or upstream of the wall portion8.

Alternatively, the control device 4 controls the stimulation device tostimulate the constricted wall portion 8 while the constriction devicevaries the constriction of the different areas of the wall portion, sothat the wall portion 8 is progressively constricted in the downstreamor upstream direction of the lumen. FIGS. 36A-36E show differentoperation stages of such an alternative embodiment. Thus, a constrictiondevice 104 used for practicing the method of the invention includes twoelongate constriction elements 105, 106 having convex surfaces 107, 108that abut a length of the wall portion 8 on mutual sides thereof. Amultiplicity of electrical elements 7 (such as electrodes) arepositioned on the convex surfaces 107, 108. The control device 4controls the electrical elements 7 during operation of the constrictiondevice 104 to stimulate the wall portion 8 and controls the elongateconstriction elements 105, 106 to move relative to the tubular wallportion 8 so that the constriction elements 105, 106 progressivelyconstrict the wall portion 8, as appears from FIGS. 36A to 36D.

Thus, in an initial position of the constriction elements 105, 106 shownin FIG. 36A, the wall portion is not constricted by the constrictionelements 105, 106 and the electrical elements 7 are not energized.Starting from this initial position, the control device 4 controls theconstriction elements 105, 106 to swing the left ends of theconstriction elements 105, 106 toward the wall portion (indicated byarrows) to constrict the tubular wall portion 8, see FIG. 36B, whileenergizing the electrical elements 7, so that the electrical elements 7that contact the wall portion 8 contract the latter. FIG. 36C shows howthe lumen of the tubular wall portion 8 is completely closed by thethickened wall portion 8. Then, as shown in FIG. 36C, the control device4 controls the constriction elements 105, 106 to move so that theirright ends are moving towards each other (indicated by arrows), whilethe convex surfaces 107, 108 of the constriction elements 105, 106 arerolling on each other with the contracted wall portion 8 between them,see FIG. 36D. As a result, the bodily matter in the lumen of the organis forced to the right (indicated by a white arrow). When theconstriction elements 105, 106 have rolled on each other to the positionshown in FIG. 36E, the control device 4 controls the right ends of theconstriction elements 105, 106 to move away from each other (indicatedby arrows in FIG. 36E) to the initial position shown in FIG. 36A. Theoperation stages described according to FIGS. 36A to 36E can becyclically repeated a number of times until the desired amount of bodilymatter has been moved in the lumen of the organ in a peristaltic manner.

Alternatively, only one of the constriction elements 105, 106 can beprovided with a convex surface, whereas the other constriction elementhas a plane surface that abuts the wall portion. It is also possible touse a single constriction element with a convex surface that presses thetubular portion 8 of the organ against a bone of the patient.

In the embodiment according to FIGS. 36A to 36E, the control device 4may control the electrical elements 7 to progressively stimulate theconstricted wall portion 8 to cause progressive contraction thereof inharmony with the movement of the elongate constriction elements 105,106, as the convex surfaces 107, 108 of the constriction elements 105,106 are rolling on each other.

FIG. 37 schematically shows a general embodiment of the apparatus of theinvention, in which energy is transferred to energy consuming componentsof the apparatus implanted in the patient.

The apparatus of FIG. 37 comprises an implanted constriction/stimulationunit 109, which is operable to gently constrict a portion of a tubulartissue wall of a patient's organ and to stimulate different areas of theconstricted portion to cause contraction of the wall portion. Theconstriction device of the constriction/stimulation unit 110 is capableof performing a reversible function, i.e., to constrict and release thewall portion, so that the constriction/stimulation unit 110 works as anartificial sphincter.

A source of energy 111 is adapted to supply energy consuming componentsof the constriction/stimulation unit 110 with energy via a power supplyline 112. A wireless remote control or a subcutaneously implanted switchoperable by the patient to switch on or off the supply of energy fromthe source of energy may be provided. The source of energy may be animplantable permanent or rechargeable battery, or be included in anexternal energy-transmission device, which may be operable directly bythe patient or be controlled by a remote control operable by the patientto transmit wireless energy to the energy consuming components of theconstriction/stimulation unit. Alternatively, the source of energy maycomprise a combination of an implantable rechargeable battery, anexternal energy-transmission device and an implantableenergy-transforming device for transforming wireless energy transmittedby the external energy-transmission device into electric energy for thecharge of the implantable rechargeable battery.

FIG. 38 shows a special embodiment of the general embodiment of FIG. 37having some parts implanted in a patient and other parts located outsidethe patient's body. Thus, in FIG. 38 all parts placed to the right ofthe patient's skin 109 are implanted and all parts placed to the left ofthe skin 109 are located outside the patient's body. An implantedenergy-transforming device 111A of the apparatus is adapted to supplyenergy consuming components of the constriction/stimulation unit 110with energy via the power supply line 112. An externalenergy-transmission device 113 of the apparatus includes a wirelessremote control transmitting a wireless signal, which is received by asignal receiver incorporated in the implanted energy-transforming device111A. The implanted energy-transforming device 111A transforms energyfrom the signal into electric energy which is supplied via the powersupply line 112 to the constriction/stimulation unit 110.

The apparatus of FIG. 3 may also include an implanted rechargeablebattery for energizing energy consuming implanted components of theapparatus. In this case, the implanted energy-transforming device 111Aalso charges the battery with electric energy, as theenergy-transforming device transforms energy from the signal into theelectric energy.

A reversing device in the form of an electric switch 114, such as amicroprocessor, is implanted in the patient for reversing theconstriction device of the constriction/stimulation unit 110. Thewireless remote control of the external energy-transmission device 113transmits a wireless signal that carries energy and the implantedenergy-transforming device 111A transforms the wireless energy into acurrent for operating the switch 114. When the polarity of the currentis shifted by the energy-transforming device 111A the switch 114reverses the function performed by the constriction device of theconstriction/stimulation unit 110.

FIG. 39 shows another embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an operation device in the form of a motor 115 for operating theconstriction device of the constriction/stimulation unit 110. The motor115 is powered with energy from the energy-transforming device 111A, asthe remote control of the external energy-transmission device113transmits a wireless signal to the receiver of the energy-transformingdevice 111A.

FIG. 40 shows yet another embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an assembly 116 including a motor/pump unit 117 and a fluidreservoir 118. In this case the constriction device of theconstriction/stimulation unit 110 is hydraulically operated, i.e.,hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir118 to the constriction/stimulation unit 110 to constrict the wallportion, and hydraulic fluid is pumped by the motor/pump unit 117 backfrom the constriction/stimulation unit 110 to the reservoir 118 torelease the wall portion. The implanted energy-transforming device 111Atransforms wireless energy into a current, for powering the motor/pumpunit 117.

FIG. 41 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 41 comprises the externalenergy-transmission device 113 that controls the control unit 122 toreverse the motor 115 when needed, the constriction/stimulation unit110, the constriction device of which is hydraulically operated, and theimplanted energy-transforming device 111A, and further comprises animplanted hydraulic fluid reservoir 119, an implanted motor/pump unit120, an implanted reversing device in the form of a hydraulic valveshifting device 121 and a separate external wireless remote control111B. The motor of the motor/pump unit 120 is an electric motor. Inresponse to a control signal from the wireless remote control of theexternal energy-transmission device 113, the implantedenergy-transforming device 111A powers the motor/pump unit 120 withenergy from the energy carried by the control signal, whereby themotor/pump unit 120 distributes hydraulic fluid between the reservoir119 and the constriction device of the constriction/stimulation unit110. The remote control 111B controls the shifting device 121 to shiftthe hydraulic fluid flow direction between one direction in which thefluid is pumped by the motor/pump unit 120 from the reservoir 119 to theconstriction device of the constriction/stimulation unit 110 toconstrict the wall portion, and another opposite direction in which thefluid is pumped by the motor/pump unit 120 back from the constrictiondevice of the constriction/stimulation unit 110 to the reservoir 119 torelease the wall portion.

FIG. 42 shows an embodiment of the invention including theenergy-transforming device 111A and the constriction/stimulation unit110. A control unit 122, an accumulator 123 and a capacitor 124 are alsoimplanted in the patient. A separate external wireless remote control111B controls the control unit 122. The control unit 122 controls theenergy-transforming device 111A to store electric energy in theaccumulator 123, which supplies energy to the constriction/stimulationunit 110. In response to a control signal from the wireless remotecontrol 111B, the control unit 122 either releases electric energy fromthe accumulator 123 and transfers the released energy via power lines,or directly transfers electric energy from the energy-transformingdevice 111A via the capacitor 124, which stabilizes the electriccurrent, for the operation of the constriction/stimulation unit 110.

In accordance with one alternative, the capacitor 124 in the apparatusof FIG. 42 may be omitted. In accordance with another alternative, theaccumulator 123 in this apparatus may be omitted.

FIG. 43 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110.A battery 125 for supplying energy for the operation of theconstriction/stimulation unit 110 and an electric switch 126 forswitching the operation of the constriction/stimulation unit 110 arealso implanted in the patient. The switch 126 is operated by the energysupplied by the energy-transforming device 111A to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 44 shows an apparatus identical to that of FIG. 43, except that acontrol unit 122 also is implanted in the patient. A separate externalwireless remote control 111B controls the control unit 122. In thiscase, the switch 126 is operated by the energy supplied by theenergy-transforming device 111A to switch from an off mode, in which thewireless remote control 111B is prevented from controlling the controlunit 122 and the battery 125 is not in use, to a standby mode, in whichthe remote control 111B is permitted to control the control unit 122 torelease electric energy from the battery 125 for the operation of theconstriction/stimulation unit 110.

FIG. 45 shows an apparatus identical to that of FIG. 44, except that theaccumulator 123 is substituted for the battery 125 and the implantedcomponents are interconnected differently. In this case, the accumulator123 stores energy from the energy-transforming device 111A. In responseto a control signal from the wireless remote control 111 B, theimplanted control unit 122 controls the switch 126 to switch from an offmode, in which the accumulator 123 is not in use, to an on mode, inwhich the accumulator 123 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 46 shows an apparatus identical to that of FIG. 45, except that thebattery 125 also is implanted in the patient and the implantedcomponents are interconnected differently. In response to a controlsignal from the wireless remote control 111B, the implanted control unit122 controls the accumulator 123, which may be a capacitor, to deliverenergy for operating the switch 126 to switch from an off mode, in whichthe battery 125 is not in use, to an on mode, in which the battery 125supplies electric energy for the operation of theconstriction/stimulation unit 110.

Alternatively, the switch 126 may be operated by energy supplied by theaccumulator 123 to switch from an off mode, in which the wireless remotecontrol 111 B is prevented from controlling the battery 125 to supplyelectric energy and the battery 125 is not in use, to a standby mode, inwhich the wireless remote control 111B is permitted to control thebattery 125 to supply electric energy for the operation of theconstriction/stimulation unit 110.

FIG. 47 shows an apparatus identical to that of FIG. 43, except that amotor 115, a mechanical reversing device in the form of a gearbox 127and a control unit 122 for controlling the gearbox 127 also areimplanted in the patient. A separate external wireless remote control111B controls the implanted control unit 122 to control the gearbox 127to reverse the function performed by the constriction device(mechanically operated) of the constriction/stimulation unit 110.

FIG. 48 shows an apparatus identical to that of FIG. 46 except that theimplanted components are interconnected differently. Thus, in this casethe battery 125 powers the control unit 122 when the accumulator 123,suitably a capacitor, activates the switch 126 to switch to an on mode.When the switch 126 is in its on mode the control unit 122 is permittedto control the battery 125 to supply, or not supply, energy for theoperation of the constriction/stimulation unit 110.

FIG. 49 shows an embodiment of the invention identical to that of FIG.39, except that a gearbox 127 that connects the motor 115 to theconstriction/stimulation unit 110, and a control unit 122 that controlsthe energy-transforming device 111A to power the motor 115 also areimplanted in the patient. There is a separate external wireless remotecontrol 111 B that controls the control unit 122 to reverse the motor115 when needed.

Optionally, the accumulator 123 shown in FIG. 42 may be provided in theembodiment of FIG. 49, wherein the implanted control unit 122 controlsthe energy-transforming device 111A to store the transformed energy inthe accumulator 123. In response to a control signal from the wirelessremote control 111B, the control unit 122 controls the accumulator 123to supply energy for the operation of the constriction/stimulation unit110.

Any of the apparatuses of FIGS. 36-49 can be used for practicing themethod of the invention.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 38-49 could be combined in many different ways. Forexample, the energy operated switch 114 could be incorporated in any ofthe embodiments of FIGS. 39, 42-49, the hydraulic shifting device 121could be incorporated in the embodiment of FIG. 40, and the gearbox 127could be incorporated in the embodiment of FIG. 39. The switch 114 maybe of a type that includes electronic components, for example amicroprocessor, or a FGPA (Field Programmable Gate Array) designed forswitching. Alternatively, however, the energy operated switch 114 may bereplaced by a subcutaneously implanted push button that is manuallyswitched by the patient between “on” and“off”.

Alternatively, a permanent or rechargeable battery may be substitutedfor the energy-transforming devices 111A of the embodiments shown inFIGS. 38-49.

FIG. 50 shows the energy-transforming device in the form of anelectrical junction element 128 for use in any of the above embodimentsaccording to FIGS. 37-49. The element 128 is a flat p-n junction elementcomprising a p-type semiconductor layer 129 and an n-type semiconductorlayer 130 sandwiched together. A light bulb 131 is electricallyconnected to opposite sides of the element 128 to illustrate how thegenerated current is obtained. The output of current from such a p-njunction element 128 is correlated to the temperature. See the formulabelow.

I=I0(exp(qV/kT)−1)

-   -   where    -   I is the external current flow,    -   I0 is the reverse saturation current,    -   q is the fundamental electronic charge of 1.602×10−19 coulombs,    -   V is the applied voltage,    -   k is the Boltzmann constant, and    -   T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −I0. I0is strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. I0 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode, that is, its restriction of current flow to onlyone direction, is in this particular embodiment the key to the operationof the p-n junction element 128.

The alternative way to design a p-n junction element is to deposit athin layer of semiconductor onto a supporting material which does notabsorb the kind of energy utilized in the respective embodiments. Foruse with wirelessly transmitted energy in terms of light waves, glasscould be a suitable material. Various materials may be used in thesemiconductor layers such as but not limited to cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 128 could beof the same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating the alternating current.

The p-n junction element 128 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 128 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly depending on temperature as shown above.Since both the skin and subcutis absorb energy, the relation between thesensitivity or working area of the element 128 and the intensity orstrength of the wireless energy-transmission is considered. The p-njunction element 128 preferably is designed flat and small.Alternatively, if the element 128 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 128 should be kept less than 2000 cm³.

FIG. 51 shows basic parts of a remote control used for practicing themethod of the invention. The remote control controls theconstriction/stimulation unit 110. In this case, the stimulation deviceof the constriction/stimulation unit stimulates the wall portion of thepatient's organ with electric pulses. The remote control is based onwireless transmission of electromagnetic wave signals, often of highfrequencies in the order of 100 kHz-1 gHz, through the skin 132 of thepatient. In FIG. 51, all parts placed to the left of the skin 132 arelocated outside the patient's body and all parts placed to the right ofthe skin 132 are implanted.

An external signal-transmission device 133 is to be positioned close toa signal-receiving device 134 implanted close to the skin 132. As analternative, the signal-receiving device 134 may be placed for exampleinside the abdomen of the patient. The signal-receiving device 134comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter,wound with a very thin wire and tuned with a capacitor to a specifichigh frequency. A small coil is chosen if it is to be implanted underthe skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The signal transmission device133 comprises a coil having about the same size as the coil of thesignal-receiving device 134 but wound with a thick wire that can handlethe larger currents that is necessary. The coil of the signaltransmission device 133 is tuned to the same specific high frequency asthe coil of the signal-receiving device 134.

The signal-transmission device 133 is adapted to send digitalinformation via the power amplifier and signal-receiving device 134 toan implanted control unit 135. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the signal transmission device 133is used to order the signal transmission device 133 to send digitalsignals for the control of the constriction/stimulation unit. The signaltransmission device 133 starts a command by generating a high frequencysignal. After a short time, when the signal has energized the implantedparts of the control system, commands are sent to operate theconstriction device of the constriction/stimulation unit 110 inpredefined steps. The commands are sent as digital packets in the formillustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new constriction or release stepis desired the Count byte is increased by one to allow the implantedcontrol unit 135 to decode and understand that another step is demandedby the signal transmission device 133. If any part of the digital packetis erroneous, its content is simply ignored.

Through a line 136, an implanted energizer unit 137 draws energy fromthe high frequency electromagnetic wave signals received by thesignal-receiving device 134. The energizer unit 137 stores the energy ina source of energy, such as a large capacitor, powers the control unit135 and powers the constriction/stimulation unit 110 via a line 138.

The control unit 135 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the signaltransmission device 133. The microprocessor receives the digital packet,decodes it and sends a control signal via a signal line 139 to controlthe constriction device of the constriction/stimulation unit 110 toeither constrict or release the wall portion of the patient's organdepending on the received command code.

FIG. 52 shows a circuitry of an embodiment of the invention, in whichwireless energy is transformed into a current. External components ofthe circuitry include a microprocessor 140, a signal generator 141 and apower amplifier 142 connected thereto. The microprocessor 140 is adaptedto switch the signal generator 141 on/off and to modulate signalsgenerated by the signal generator 141 with digital commands. The poweramplifier 142 amplifies the signals and sends them to an externalsignal-transmitting antenna 143. The antenna 143 is connected inparallel with a capacitor 144 to form a resonant circuit tuned to thefrequency generated by the signal generator 141.

Implanted components of the circuitry include a signal receiving antennacoil 145 and a capacitor 146 forming together a resonant circuit that istuned to the same frequency as the transmitting antenna 143. The signalreceiving antenna coil 145 induces a current from the received highfrequency electromagnetic waves and a rectifying diode 147 rectifies theinduced current, which charges a storage capacitor 148. The storagecapacitor 148 powers a motor 149 for driving the constriction device ofthe constriction/stimulation unit 110. A coil 150 connected between theantenna coil 145 and the diode 147 prevents the capacitor 148 and thediode 147 from loading the circuit of the signal-receiving antenna 145at higher frequencies. Thus, the coil 150 makes it possible to chargethe capacitor 148 and to transmit digital information using amplitudemodulation.

A capacitor 151 and a resistor 152 connected in parallel and a diode 153forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 154 connected in series with aresistor 155 connected in series with a capacitor 156 connected inseries with the resistor 154 via ground, and a capacitor 157, oneterminal of which is connected between the resistors 154,155 and theother terminal of which is connected between the diode 153 and thecircuit formed by the capacitor 151 and resistor 152. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 158 thatdecodes the digital information and controls the motor 149 via anH-bridge 159 comprising transistors 160,161,162 and 163. The motor 149can be driven in two opposite directions by the H-bridge 159.

The microprocessor 158 also monitors the amount of stored energy in thestorage capacitor 148. Before sending signals to activate the motor 149,the microprocessor 158 checks whether the energy stored in the storagecapacitor 148 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 158 waits for the receivedsignals to charge the storage capacitor 148 before activating the motor149.

Alternatively, the energy stored in the storage capacitor 148 may onlybe used for powering a switch, and the energy for powering the motor 149may be obtained from another implanted energy source of relatively highcapacity, for example a battery. In this case the switch is adapted toconnect the battery to the motor 149 in an on mode when the switch ispowered by the storage capacitor 148 and to keep the batterydisconnected from the motor 149 in a standby mode when the switch is notpowered.

FIGS. 53A-53C show an apparatus used for practicing the method of theinvention which is similar to the apparatus of FIG. 2, except that theconstriction/stimulation unit, here denoted by reference numeral 200, isprovided with additional clamping elements. The apparatus of FIGS.53A-53C is suited for actively moving the fluid and/or other bodilymatter in the lumen of a patient's organ. Thus, theconstriction/stimulation unit 200 also includes a first pair of shortclamping elements 201 and 202, and a second pair of short clampingelements 203 and 204, wherein the first and second pairs of clampingelements are positioned at mutual sides of the elongate clampingelements 5,6. The two short clamping elements 201, 202 of the first pairare radially movable towards and away from each other between retractedpositions (FIG. 53A) and clamping positions (FIGS. 53B and 53C), and thetwo short clamping elements 203, 204 of the second pair are radiallymovable towards and away from each other between retracted positions(FIG. 53C) and clamping positions (FIGS. 53A and 53B). The stimulationdevice 3 also includes electrical elements 7 positioned on the shortclamping elements 201-204, so that the electrical elements 7 on one ofthe short clamping elements 201 and 203, respectively, of each pair ofshort elements face the electrical elements 7 on the other shortclamping element 202 and 204, respectively, of each pair of shortelements.

The constriction/stimulation unit 200 is applied on a wall portion 8 ofa tubular tissue wall of a patient's organ, so that the short clampingelements 201, 202 are positioned at an upstream end of the wall portion8, whereas the short clamping elements 203, 204 202 are positioned at adownstream end of the wall portion 8. In FIGS. 53A to 53C the upstreamend of the wall portion 8 is to the left and the downstream end of thewall portion 8 is to the right.

The control device 4 controls the pair of short clamping elements 201,202, the pair of elongate clamping elements 5, 6 and the pair of shortelements 203, 204 to constrict and release the wall portion 8independently of one another. The control device also controls theelectrical elements 7 on a clamping element that is constricting thewall portion to stimulate the constricted wall portion 8 with electricpulses to cause contraction of the wall portion 8, so that the lumen ofthe wall portion 8 is closed.

FIGS. 53A-53C illustrate how the control device 4 controls the operationof the constriction/stimulation unit 200 to cyclically move fluid and/orother bodily matter downstream in the lumen of the wall portion 8. Thus,in FIG. 53A the short clamping elements 201, 202 and the elongateclamping elements 5, 6 are in their retracted positions, whereas theshort clamping elements 203, 204 are in their clamping positions whilethe electrical elements 7 on elements 203, 204 electrically stimulatethe wall portion 8. The electrical stimulation causes the wall portion 8at the elements 203, 204 to thicken, whereby the lumen is closed. FIG.53B illustrates how also the short clamping elements 201, 202 have beenmoved radially inwardly to their clamping positions while the electricalelements 7 on elements 201, 202 electrically stimulate the wall portion8, whereby a volume of bodily matter is trapped in the lumen between theupstream and downstream ends of the wall portion 8. FIG. 53C illustrateshow initially the short clamping elements 203, 204 have been movedradially outwardly to their retracted positions, and then the elongateclamping elements 5, 6 have been moved radially inwardly to theirclamping positions while the electrical elements 7 on elements 5, 6electrically stimulate the wall portion 8. As a result, the bodilymatter in the lumen between the upstream and downstream ends of the wallportion 8 has been moved downstream in the lumen as indicated by anarrow. Then, the control device 4 controls the constriction/stimulationunit 200 to assume the state shown in FIG. 53A, whereby bodily mattermay flow into and fill the lumen between the upstream and downstreamends of the wall portion 8, so that the cycle of the operation iscompleted.

Alternatively, the operation cycle of the constriction/stimulation unit200 described above may be reversed, in order to move bodily matterupstream in the lumen. In this case the control device 4 controls theshort clamping elements 203, 204 to constrict the wall portion 8 at thedownstream end thereof to restrict the flow in the lumen and controlsthe electric elements 7 to stimulate the constricted wall portion 8 withelectric pulses at the downstream end to close the lumen. With the lumenclosed at the downstream end of the constricted wall portion 8 and theshort clamping elements 201, 202 in their retracted positions, as shownin FIG. 53A, the control device 4 controls the elongate clampingelements 5, 6 to constrict the wall portion 8 between the upstream anddownstream ends thereof. As a result, the fluid and/or other bodilymatter contained in the wall portion 8 between the upstream anddownstream ends thereof is moved upstream in the lumen.

Although FIGS. 53A-53C disclose pairs of clamping elements, it should benoted that it is conceivable to design the constriction/stimulation unit200 with only a single short clamping element 201, a single elongateclamping element 5 and a single short clamping element 203. In this casethe bottom of the tubular wall portion 8 is supported by stationaryelements of the constriction/stimulation unit 200 opposite to theclamping elements 201, 5, 203.

FIGS. 54A and 54B schematically show another apparatus used forpracticing the method of the invention, in particular for activelymoving the fluid and/or other bodily matter in the lumen of a patient'stubular organ. The apparatus of FIGS. 54A and 54B includes aconstriction/stimulation unit 205, the constriction device 206 of whichhas a rotor 207, which carries three cylindrical constriction elements208A, 208B and 208C positioned equidistantly from the axis 209 of therotor 207. The constriction elements 208A-208C may be designed asrollers. Each cylindrical element 208A-208C is provided with electricalelements 7. A stationary elongate support element 210 is positionedspaced from but close to the rotor 207 and has a part cylindricalsurface 211 concentric with the axis 209 of the rotor 207. Theconstriction/stimulation unit 205 is applied on a patient's tubularorgan 212, so that the organ 212 extends between the support element 210and the rotor 207.

The control device 4 controls the rotor 207 of the constriction deviceto rotate so that the constriction elements 208A-208C successivelyconstrict wall portions of a series of wall portions of the tubularorgan 212 against the elongate support element 210. The electricalelements 7 of the constriction elements 208A-208C stimulate theconstricted wall portions with electric pulses so that the wall portionsthicken and close the lumen of the organ 212. FIG. 54A illustrates howthe constriction element 208A has started to constrict the wall of theorgan 212 and how the lumen of the organ 212 is closed with the aid ofthe electrical elements 7 on the constriction element 208A, whereas theconstriction element 208B is about to release the organ 212. FIG. 54Billustrates how the constriction element 208A has advanced about halfwayalong the elongate support element 210 and moved the bodily matter inthe lumen in a direction indicated by an arrow. The constriction element208B has released the organ 212, whereas the constriction element 208Cis about to engage the organ 212. Thus, the control device 4 controlsthe rotor 207 to cyclically move the constriction elements 208A-208C oneafter the other along the elongate support element 210 whileconstricting the wall portions of the organ 212, so that the bodilymatter in the organ 212 is moved in a peristaltic manner.

FIGS. 55A, 55B and 55C show another mechanically operable constrictiondevice 213 used for practicing the method of the invention. Referring toFIG. 55A, the constriction device 213 includes a first ring-shapedholder 214 applied on a tubular organ 8 of a patient and a secondring-shaped holder 215 also applied on the organ 8 spaced apart fromholder 214. There are elastic strings 216 (here twelve strings) thatextend in parallel along the tubular organ 8 and interconnect the twoholders 213, 214 without contacting the organ 8. FIG. 55A illustrate aninactivated state of the constriction device 213 in which the organ 8 isnot constricted.

Referring to FIGS. 55B and 55C, when organ 8 is to be constricted thering-shaped holders 213 and 214 are rotated by an operation means (notshown) in opposite directions, whereby the elastic strings 216 constrictthe organ 8 in a manner that appears from FIGS. 55B and 55C. For thesake of clarity, only five strings 216 are shown in FIG. 55B.

In accordance with the present invention, electrodes for electricallystimulating the organ 8 to cause contraction of the wall of the organ 8are attached to the strings 216 (not shown in FIGS. 55A-55C).

FIG. 56 schematically illustrates an arrangement capable of sendinginformation from inside the patient's body to the outside thereof togive information related to at least one functional parameter of theapparatus, and/or related to a physical parameter of the patient, inorder to supply an accurate amount of energy to an implanted internalenergy receiver 302 connected to energy consuming components of animplanted constriction/stimulation unit 301 of the apparatus. Such anenergy receiver 302 may include a source of energy and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external source of energy 304 a located outside thepatient and is received by the internal energy receiver 302 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the constriction/stimulation unit 301 via a switch 326. An energybalance is determined between the energy received by the internal energyreceiver 302 and the energy used for the constriction/stimulation unit301, and the transmission of wireless energy is then controlled based onthe determined energy balance. The energy balance thus provides anaccurate indication of the correct amount of energy needed, which issufficient to operate the constriction/stimulation unit 301 properly,but without causing undue temperature rise.

In FIG. 56 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external source of energy 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal source of energy 304 a and an adjacent secondary coil arrangedin the implanted energy-transforming device 302. When an electriccurrent is fed through the primary coil, energy in the form of a voltageis induced in the secondary coil which can be used to power theimplanted energy consuming components, e.g. after storing the incomingenergy in an implanted source of energy, such as a rechargeable batteryor a capacitor. However, the present invention is generally not limitedto any particular energy transfer technique, TET devices or energysources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalsource of energy 304 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 315 connected between the switch 326 andthe constriction/stimulation unit 301. The internal control unit 315 maythus be arranged to receive various measurements obtained by suitablesensors or the like, not shown, measuring certain characteristics of theconstriction/stimulation unit 301, somehow reflecting the requiredamount of energy needed for proper operation of theconstriction/stimulation unit 301. Moreover, the current condition ofthe patient may also be detected by means of suitable measuring devicesor sensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the constriction/stimulation unit 301, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by parametyers such as: body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere.

Furthermore, a source of energy in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the constriction/stimulation unit 301. Alternatively or additionally,characteristics of such an accumulator, also reflecting the requiredamount of energy, may be measured as well. The accumulator may bereplaced by a rechargeable battery, and the measured characteristics maybe related to the current state of the battery, any electrical parametersuch as energy consumption voltage, temperature, etc. In order toprovide sufficient voltage and current to the constriction/stimulationunit 301, and also to avoid excessive heating, it is clearly understoodthat the battery should be charged optimally by receiving a correctamount of energy from the implanted energy-transforming device 302, i.e.not too little or too much. The accumulator may also be a capacitor withcorresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus, or the patient, or an implanted source ofenergy if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal source of energy 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 56employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components. The apparatus may use the received energyeither for consuming or for storing the energy in an implanted source ofenergy or the like. The different parameters discussed above would thusbe used if relevant and needed and then as a tool for determining theactual energy balance. However, such parameters may also be needed perse for any actions taken internally to specifically operate theapparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external source of energy 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. Such an integrated information feedbackand energy system comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises a powerswitch for switching the connection of the internal first coil to thefirst electronic circuit on and off, such that feedback informationrelated to the charging of the first coil is received by the externalenergy transmitter in the form of an impedance variation in the load ofthe external second coil, when the power switch switches the connectionof the internal first coil to the first electronic circuit on and off.In implementing this system in the arrangement of FIG. 17, the switch326 is either separate and controlled by the internal control unit 315,or integrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 56 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external source of energy 304 a can then be regulatedby the external control unit 304 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external source of energy 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics. This system may also be used to obtain informationabout the coupling factors between the coils in a TET system even tocalibrate the system both to find an optimal place for the external coilin relation to the internal coil and to optimize energy transfer. Simplycomparing in this case the amount of energy transferred with the amountof energy received. For example if the external coil is moved thecoupling factor may vary and correctly displayed movements could causethe external coil to find the optimal place for energy transfer.Preferably, the external coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 57, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 57,wherein an external switch 326 is interconnected between the externalsource of energy 304 a and an operation device, such as an electricmotor 307 operating the constriction/stimulation unit 301. An externalcontrol unit 304 b controls the operation of the external switch 326 toeffect proper operation of the constriction/stimulation unit 301.

FIG. 58 illustrates different embodiments for how received energy can besupplied to and used by the constriction/stimulation unit 301. Similarto the example of FIG. 56, an internal energy receiver 302 receiveswireless energy E from an external source of energy 304 a which iscontrolled by a transmission control unit 304 b. The internal energyreceiver 302 may comprise a constant voltage circuit, indicated as adashed box “constant V” in FIG. 58, for supplying energy at constantvoltage to the constriction/stimulation unit 301. The internal energyreceiver 302 may further comprise a constant current circuit, indicatedas a dashed box “constant C” in the figure, for supplying energy atconstant current to the constriction/stimulation unit 301.

The constriction/stimulation unit 301 comprises an energy consuming part301 a, which may be a motor, pump, restriction device, or any othermedical appliance that requires energy for its electrical operation. Theconstriction/stimulation unit 301 may further comprise an energy storagedevice 301 b for storing energy supplied from the internal energyreceiver 302. Thus, the supplied energy may be directly consumed by theenergy consuming part 301 a, or stored by the energy storage device 301b, or the supplied energy may be partly consumed and partly stored. Theconstriction/stimulation unit 301 may further comprise an energystabilizing unit 301 c for stabilizing the energy supplied from theinternal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the constriction/stimulation unit 301, before beingconsumed and/or stored by the constriction/stimulation unit 301.Alternatively, the energy stabilizing unit 328 may be integrated in theinternal energy receiver 302. In either case, the energy stabilizingunit 328 may comprise a constant voltage circuit and/or a constantcurrent circuit.

It should be noted that FIG. 56 and FIG. 58 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 59 schematically shows an energy balance measuring circuit of oneof the proposed designs of the apparatus for controlling transmission ofwireless energy, or energy balance. The circuit has an output signalcentered on 2.5V and proportionally related to the energy imbalance. Thederivative of this signal shows if the value goes up and down and howfast such a change takes place. If the amount of received energy islower than the energy used by implanted components of the apparatus,more energy is transferred and thus charged into the source of energy.The output signal from the circuit is typically fed to an ND converterand converted into a digital format. The digital information can then besent to the external energy-transmission device allowing it to adjustthe level of the transmitted energy. Another possibility is to have acompletely analog system that uses comparators comparing the energybalance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 59 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatusfrom outside of the patient's body using inductive energy transfer. Aninductive energy transfer system typically uses an external transmittingcoil and an internal receiving coil. The receiving coil, L1, is includedin the schematic FIG. 59; the transmitting parts of the system areexcluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 59 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

The embodiments described in connection with FIGS. 56, 58 and 59identify a general method of the present invention for controllingtransmission of wireless energy to implanted energy consuming componentsof the apparatus. Such a method will be defined in general terms in thefollowing.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal source of energy located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the implanted energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto. An energy balance is determined between theenergy received by the internal energy receiver and the energy used forthe operation of the implanted parts of the apparatus. The transmissionof wireless energy E from the external source of energy is thencontrolled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external source of energy to a secondary coil in the internalenergy receiver. A change in the energy balance may be detected tocontrol the transmission of wireless energy based on the detected energybalance change. A difference may also be detected between energyreceived by the internal energy receiver and energy used for theoperation of the implanted parts of the apparatus, to control thetransmission of wireless energy based on the detected energy difference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the operation of the implantedparts of the apparatus be consumed to operate the implanted parts of theapparatus and/or stored in at least one implanted energy storage deviceof the apparatus.

When electrical and/or physical parameters of the implanted parts of theapparatus and/or physical parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external source of energymay be controlled by applying to the external source of energyelectrical pulses from a first electric circuit to transmit the wirelessenergy, the electrical pulses having leading and trailing edges, varyingthe lengths of first time intervals between successive leading andtrailing edges of the electrical pulses and/or the lengths of secondtime intervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external sourceof energy may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A constriction device can be arranged to delay the movement of thebodily matter in a lumen of the organ for a predetermined amount oftime. This can be achieved in many different ways, of which two will bedescribed below.

FIG. 60 is a sectional view through a constriction device 2 adapted torestrict or stop the flow through an luminal organ. The general flowdirection is illustrated by an arrow. The constriction device comprisesan array of constriction elements 2 a-2 m, each arranged to restrict orclose a part of the luminal organ. The constriction device illustratedin FIG. 56 is in an open or non-operative position wherein the flow isuninterrupted

FIG. 61A illustrates the constriction device of FIG. 60 in a firstinterrupting stage, wherein every other constriction element is in aclosed position. A bodily matter, generally designated 1000, is allowedto enter the space formed by the first, non-closed constriction element.It is stopped there by the second constriction element, which is in aclosed position. This operative state can remain for a desired period oftime, such as one day.

FIG. 61B illustrates the constriction device of FIG. 60 in a secondinterrupting stage, wherein every constriction element that was closedin the first interrupting stage is in an open position and vice versa.The bodily matter is then allowed to enter the space formed by thesecond, non-closed constriction element. It is stopped there by thethird constriction element, which is in a closed position. Thisoperative state can remain for a desired period of time, such as oneday.

FIG. 61A illustrates the constriction device of FIG. 60 in a thirdinterrupting stage, wherein every other constriction element is in aclosed position, exactly as in the first interrupting stage. The bodilymatter shown in

FIGS. 61A and 61B, is allowed to enter the space formed by the third,non-closed constriction element. It is stopped there by the fourthconstriction element, which is in a closed position. This operativestate can remain for a desired period of time, such as one day.

Repeating this process, the movement of a bodily matter can be delayedfor a desired period of time until it reaches the other end of theconstriction device. Since the life of a bodily matter is less thanabout five days, delaying a bodily matter in this way will ensure thatit does not reach an egg in the luminal organ and thereby theconstriction device functions to prevent any flow of bodily matter. Byaltering the constricted area of the luminal organ, this will not beharmed like if the same area were constricted for a longer period oftime.

FIGS. 62A-D show a second embodiment of a constriction device. Thisoperates in a way similar to the first embodiment of a constrictiondevice shown in FIGS. 61A-C. However, in this embodiment, twoconsecutive constriction elements are in an open position at a time whenallowing progress of the bodily matter.

FIG. 63A-E disclose one particular embodiment of the invention using apump for a lumenal organ to such bodily matter in the luminal organ. Theprinciple is simple; more than one restriction device is supplied on theoutside of the organ to restrict the same from the outside thereof. Therestriction device may comprise any one of or a combination of; astimulation device, a mechanical or hydraulic restriction device. Onefirst restriction is applied and restricted. At least one furtherrestriction is then applied. Preferable the restriction applies slowlyto not cause any unnecessary movement of any bodily matter backwards.The further restrictions preferable has a longer restricted area.Thereafter all the restrictions are rapidly released causing suctionboth from the proximal and distal side. As long as the restriction isapplied slowly and released fast any way to apply the restriction mayalternatively work.

FIG. 63A disclose an applied restriction on the luminal organ with arestriction device 2. FIG. 63 B-D disclose further applied restrictions.FIG. 63E disclose a rapid release of all the restriction areas at thesame time thus creating a suction from both sides or if one restrictionmost distal or most proximal is not released sucking from only one side.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

1-302. (canceled)
 303. An apparatus for controlling a flow of urine in aurethra of a patient, comprising: an implantable constriction device forconstricting the urethra to influence the flow in the urinary tract, theconstriction device comprising a plurality of constriction elementsconfigured to be arranged at different locations along the flowdirection of the urethra; wherein each constriction element isconfigured to at least partly encircle the urethra and to be operable soas to change a constriction of the urethra; and wherein the apparatusfurther comprises an operation device configured to operate theconstriction elements.
 304. The apparatus according to claim 303,wherein the constriction elements are configured to be operatedindependently from each other.
 305. The apparatus according to claim 303or 304, wherein each constriction element comprises an elongated coreconfigured to at least partly encircle the urethra.
 306. The apparatusaccording to claim 305, wherein the operation device is configured tomove the end portions of the elongated core towards and away from eachother so as to vary the constriction of the urethra.
 307. The apparatusaccording to claim 306, further comprising an implantable motorconfigured to operate the operation device.
 308. The apparatus accordingto claim 307, further comprising a gear box configured to transfer aforce generated by the motor into a force operating on the operationdevice.
 309. The apparatus according to claim 303 or 304, furthercomprising: a control device for controlling the operation device,wherein the control device is configured to: control the operationdevice to constrict the urethra, and control the operation device torelease the urethra; and an energy source for supplying energy to theoperation device; wherein the control device is configured to determinethe current state of the energy source, and wherein the control unit isconnected to an internal signal transmitter configured to transmitinformation related to the current state of the energy source.
 310. Theapparatus according to claim 309, wherein the energy source comprises abattery.
 311. The apparatus according to claim 310, wherein the batteryis at least one of a rechargeable battery and a capacitor.
 312. Theapparatus according to claim 309 or 310, wherein the control device isconfigured to measure a parameter related to a voltage of the energysource to determine the current state of the energy source.
 313. Theapparatus according to claim 309 or 310, wherein the control device isconfigured to measure a parameter related to the energy consumption todetermine the current state of the energy source.
 314. The apparatusaccording to claim 309 or 310, wherein the control device is configuredto measure a parameter related to the temperature of the energy sourceto determine the current state of the energy source.
 315. The apparatusaccording to claim 309 or 310, wherein the control device is arranged tostore measurements related to a current state of the energy source. 316.The apparatus according to claim 315, wherein the control device isarranged to transmit a control signal reflecting at least a portion ofthe stored measurements.
 317. The apparatus according to claim 309 or310, wherein the control device is arranged to measure a current stateof the energy source on a regular basis.
 318. The apparatus according toclaim 303 or 304, further comprising: a control device for controllingthe constriction device, wherein the control device is configured tocontrol the constriction device to constrict the urethra or to release aconstriction of the urethra; and an operation device for operating theconstriction device to change the constriction of the urethra; and anenergy source for supplying energy for the operation device; wherein thecontrol device comprises a temperature sensor configured to sense atemperature of the apparatus or a temperature of the patient.
 319. Theapparatus according to claim 318, wherein the control device furthercomprises an internal signal transmitter arranged to transmit a signalbased on the temperature measurements.
 320. The apparatus according toclaim 319, wherein the internal signal transmitter is arranged totransmit the signal to an external signal receiver.
 321. The apparatusaccording to any of claim 318 or 319, wherein the temperature sensor isconfigured to measure the temperature on a regular basis, and whereinthe control device is configured to store the measured values.
 322. Theapparatus according to claim 318 or 319, wherein the control devicefurther comprises an implantable sensor configured to sense a physicalparameter, and wherein the control device is adapted to produce anindication in response to the sensor sensing the physical parameter.